Animas Corporation

Model IR 1200

General Hospital and Personal Use Devices

2

No

The products are shipped to diabetic supply companies in FK, NE, NV, NJ, NY, OH, OK, TX, VA, and WA then further shipped to patients nationwide. The products were shipped to government accounts in IL, MD, and SC. The product was also shipped to a supply company in Israel.

IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C.

Model IR1250

General Hospital and Personal Use Devices

2

No

The products were shipped to distributors in FL, TX, UT, and VA. The products were also shipped to patients nationwide.

Animas IR 1250 Insulin Pump.

Animas 2020 Insulin Pump  Serial numbers 00-89133-12, 00-89207-12, 14-88703-12, 14-88710-12, 15-88704-12, 15-89190-12, 16-89096-12, 16-89191-12, 17-88720-12, 17-89097-12, 17-89185-12, 17-89611-12, 18-88721-12, 18-89612-12, 19-88715, 18-89099-12, 19-89187-12, 19-89194-12, 19-89620-12, 20-88716-12, 20-89188-12, 20-89621-12, 21-88717-12, 21-88731-12, 21-89196-12, 21-89615-12, 22-88732-12, 22-89616-12, 23-88733-12, 24-88734-12, 25-88728-12, 25-88735-12, 27-88737-12, 28-88738-12, 33-89824-12, 35-89819-12, 36-89827-12, 88-89100-12, 91-89110-12, 92-89111-12, 93-89112-12, 94-89106-12, 94-89120-12, 95-89107-12, 95-89114-12, 95-89121-12, 96-89115-12, 21-88386-12, 21-88393-12, 22-88387-12, 96-89122-12, 96-89210-12, 97-89116-12, 97-89123-12, 97-89130-12, 01-89215-12, 02-89216-12, 02-89223-12, 02-89230-12, 03-89217-12, 03-89224-12, 03-89400-12, 04-89218-12, 04-89225-12, 04-89232-12, 04-89401-12, 05-89219-12, 05-89226-12, 06-89227-12, 06-89234-12, 06-89241-12, 06-89410-12, 07-89235-12, 07-89242-12, 07-89404-12, 07-89411-12, 08-89236-12, 08-89412-12, 09-89237-12, 09-89406-12, 09-89413-12, 10-89238-12, 10-89414-12, 11-89239-12, 11-89408-12, 11-89415-12, 12-89409-12, 13-89417-12, 14-89418-12, 14-89520-12, 15-89521-12, 17-89509-12, 17-89516-12, 18-89517-12, 18-98524-12, 18-89531-12, 19-89525-12, 29-88672-12, 32-88668-12, 32-88682-12, 20-89533-12, 20-89540-12, 21-88643-12, 21-89541-12, 22-89528-12, 22-89535-12, 22-89542-12, 23-88638-12, 23-88740-12, 24-88741-12, 24-89544-12, 25-88647-12, 26-88655-12, 26-89553-12, 27-88751-12, 27-89385-12, 27-89554-12, 27-89561-12, 28-88745-12, 28-89555-12, 29-88760-12, 29-89556-12, 29-89563-12, 30-88747-12, 30-88754-12, 30-88761-12, 30-89395-12, 31-88755-12, 31-88762-12, 31-89558-12, 32-88756-12, 32-89397-12, 33-88757-12, 33-88771-12, 34-88758-12, 34-88772-12, 35-88759-12, 35-88766-12, 36-88774-12, 37-88768-12, 39-88777-12, 39-88939-12, 41-88948-12, 42-88787-12, 51-88979-12, 03-88414-12, 10-89245-12, 33-88690-12, 40-88697-12, 98-89131-12, 14-89256-12, 15-89257-12, 16-89258-12, 17-89273-12, 18-89267-12, 19-89444-12, 20-89269-12, 21-89460-12, 22-88901-12, 22-89461-12, 24-89463-12, 26-88905-12, 27-89466-12, 33-88852-12, 34-88853-12, 35-88854-12, 36-88855-12, 37-88856-12, 39-88872-12, 41-88874-12, 43-88869-12, 47-88887-12, 99-88403-12, 00-88404-12, 00-88411-12, 01-88412-12, 02-88406-12, 02-88413-12, 03-88407-12, 04-88408-12, 04-88415-12, 12-88370-12, 13-88371-12, 14-88372-12, 15-88373-12, 16-88367-12, 16-88381-12, 17-88375-12, 18-88376-12, 18-88383-12, 18-88390-12, 19-88377-12, 19-88384-12, 19-88391-12, 20-88378-12, 20-88385-12, 20-88392-12, 44-88789-12, 00-89140-12, 01-89141-12, 64-83146-12, 00-89221-12, 05-89240-12, 17-89266-12, 22-88394-12, 23-88388-12, 23-88395-12, 24-88389-12, 24-88396-12, 25-88397-12, 26-88398-12, 27-88399-12, 96-88400-12, 99-88410-12, 38-88695-12, 41-88698-12, 09-88603-12, 10-88604-12, 12-88606-12, 12-88613-12, 13-88614-12, 15-88616-12, 22-88637-12, 20-88642-12, 22-88644-12, 23-88645-12, 24-88646-12, 12-89180-12, 08-88602-12, 11-88605-12, 11-88612-12, 19-88627-12, 21-88629-12, 33-88588-12, 51-88993-12, 54-88989-12, 54-88996-12, 86-89003-12, 89-89013-12, 90-89007-12, 92-89016-12, 97-89028-12, 98-89029-12, 19-88641-12, 27-88656-12, 27-88663-12, 27-88670-12, 29-88658-12, 35-88678-12, 35-88685-12, 36-88679-12, 36-88686-12, 36-88950-12, 37-88951-12, 38-88952-12, 39-88953-12, 40-88947-12, 40-88954-12, 41-88955-12, 42-88949-12, 42-88963-12, 27-88920-12, 30-88923-12, 32-88932-12, 33-88933-12, 34-88927-12, 35-88928-12, 35-88935-12, 18-88802-12, 21-88805-12, 23-88807-12, 33-88838-12, 02-89135-12, 03-89136-12, 04-89144-12, 06-89160-12, 08-89148-12, 11-89077-12, 11-89158-12, 12-89159-12, 12-89173-12, 13-89167-12, 18-89179-12, 23-89293-12, 24-89294-12, 25-89295-12, 00-89126-12, 02-89128-12, 03-89129-12, 13-88702-12, 16-88705-12, 17-88706-12, 99-89125-12, 25-88742-12, 26-88743-12, 27-88744-12, 28-88752-12, 29-88739-12, 29-88746-12, 31-88748-12, 32-88749-12, 32-88763-12, 32-88770-12, 34-88765-12, 35-88773-12, 35-88780-12, 38-88769-12, 38-88776-12, 40-88778-12, 15-88380-12, 16-88374-12, 17-88368-12, 17-88382-12, 18-88369-12, 21-88379-12, 32-88851-12, 42-88868-12, 07-89330-12, 11-89334-12, 19-88803-12, 19-88810-12, 21-88812-12, 22-88820-12, 24-88808-12, 25-88809-12, 25-88816-12, 25-88830-12, 26-88831-12, 27-88818-12, 27-88832-12, 29-88827-12, 29-88834-12, 30-88828-12, 31-88829-12, 31-88836-12, 32-88837-12, 01-89303-12, 02-89142-12, 03-89150-12, 04-89151-12, 05-89138-12, 05-89145-12, 06-89139-12, 07-89161-12, 08-89155-12, 09-89149-12, 09-89156-12, 10-89083-12, 10-89090-12, 10-89157-12, 10-89171-12, 11-89165-12, 13-89174-12, 13-89181-12, 14-89094-12, 14-89168-12, 14-89175-12, 15-89176-12, 20-89276-12, 20-89290-12, 21-89277-12, 21-89291-12, 22-89278-12, 22-89292-12, 25-89288-12, 26-89289-12, 26-89296-12, 27-89297-12, 29-89299-12, 30-88930-12, 12-88701-12, 05-89233-12, 26-88750-12, 37-88775-12, 10-89164-12, 36-88693-12, 39-88696-12, 32-88675-12, 33-88676-12, and 30-88835-12.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution: Nationwide (USA) distribution including the states of CA, CO, MA, and MD; and the countries of Australia, Finland, France, Israel, Italy, Sweden and the U.K.

Animas 2020 Insulin Infusion Pump. || Animas Corp. || An insulin infusion.

Part number 101420-00, 10142100, 101422-00, 101424-00, 101425-00, 100430-00, 100431-00, 100432-00, 100434-00, 100435-00, 101420-98, 101421-98, 101422-98, 101424-98, 101425-98, and 10050000.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution, (USA) including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada and the territory of Puerto Rico.

OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.

OneTouch(R) Ping(TM) Glucose Management Systems - Part Numbers 101420-00, 101421-00, 101422-00, 101424-00, 101425-00, 100430-00, 100431-00, 100432-00, 100434-00, 100435-00, 101420-98, 101421-98, 101422-98, 101424-98, and 101425-98;   Animas(R) 2020 Insulin Infusion Pumps - Part numbers 101370-00, 101371-00, 101372-00, 101374-00, 101375-00, 100380-00, 100381-00, 100382-00, 100384-00, and 100385-00;   Animas(R) IR 1250 (1200 Plus) Insulin Infusion Pumps -- Part numbers 100250-00, 100251-00, and 100252-00; and   Animas(R) IR 1200 Insulin Infusion Pumps - Part numbers 100200-00, 100201-00, and 100202-00. Serial numbers -- will be provided.

General Hospital and Personal Use Devices

2

No

Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, V, VT, WA, WI, WV, WY and Washington, DC and countries of: Austria, Australia, Canada, Czech Republic, France, Finland, Germany, Hungary, Israel, Italy, Mexico, New Zealand, Puerto Rico, Spain, and United Kingdom.

IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. || The device is intended to deliver insulin therapy.