FDA.reportPublic FDA data

OneTouch Ping

Primary DI
10840406100976
Brand
OneTouch Ping
Company
ANIMAS CORPORATION
Model
10543100
Catalog number
10543100
Device description
OTP PUMP W/O KIT, BK, US
Published
2016-08-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZGPUMP, INFUSION, INSULIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZGPump, Infusion, InsulinGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840406101072Direct MarkingGS10
10840406100976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084040610107210840406101072
1084040610097610840406100976

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithmA portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of insulin based on a continuous scalar algorithm. It may be badge-like, designed to adhere to skin or clothing or worn in a case attached to the belt or carried in a pocket and includes a reservoir, a pumping mechanism, and an infusion-rate controller. It may also allow additional manual administration/infusion and functionality to send data to a remote reporting system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)937-7867xx@xx.xx

Regulatory Flags#

DUNS number
968998641
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00353885010207OneTouch Ping023-0492017-09-13
10840406100051Animas Vibe11451100114511002015-09-17
10840406100013Animas Vibe11420000114200002015-09-17
10840406100136Animas 2.0 mL Cartridge10012402100124022015-09-17
10840406100334Animas Vibe11651000116510002015-11-16
10840406100570Animas Vibe11851000118510002016-03-14
10840406100839OneTouch Ping10143500101435002016-08-18
10840406103106Animas Vibe13920000139200002018-01-15
10840406103823Animas Vibe10255100102551002017-09-21
10840406100112Animas Vibe11420000114200002015-09-17
10840406100020Animas Vibe11420400114204002015-09-17
10840406100037Animas Vibe11420200114202002015-09-17
10840406100044Animas Vibe11451000114510002015-09-17
10840406100068Animas Vibe11451400114514002015-09-17
10840406100075Animas Vibe11451500114515002015-09-17
10840406100082Animas Vibe11451200114512002015-09-17
10840406100099Animas Vibe11420100114201002015-09-17
10840406100105Animas Vibe11420500114205002015-09-17
10840406100129Animas 2.0 mL Cartridge10012402100124022015-09-17
10840406100181Animas Vibe11551000115510002015-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850037806034PIVOT Insulin Pump ReplacementModular Medical, Inc.LZG2026-05-26
00850037806072PIVOT InserterModular Medical, Inc.LZG2026-05-26
00850037806133PIVOT Supply Kit (1pk)Modular Medical, Inc.LZG2026-05-26
00850037806164Pivot App for iOSModular Medical, Inc.LZG2026-05-26
00850037806089PIVOT Supply Kit (5pk)Modular Medical, Inc.LZG2026-05-18
00850037806140PIVOT Insulin Pump Starter KitModular Medical, Inc.LZG2026-05-18
10385082000009Omnipod DASH PDMInsulet CorporationLZG2025-08-25
00850037806003MODD1 Adhesive Pad, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806027MODD1 Insulin Cartridge, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806041MODD1 Infusion Set, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806096MODD1 PumpModular Medical, Inc.LZG2025-07-11
10850037806000MODD1 Adhesive Pad, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806010MMI App for iOSModular Medical, Inc.LZG2025-07-11
10850037806024MODD1 Insulin Cartridge, 10 PackModular Medical, Inc.LZG2025-07-11
10850037806048MODD1 Infusion Set, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806065MODD1 Supply KitModular Medical, Inc.LZG2025-07-11
00850037806102MODD1 PumpModular Medical, Inc.LZG2025-07-11
00850037806119MODD1 Starter KitModular Medical, Inc.LZG2025-07-11
00850037806126MODD1 Patient Welcome KitModular Medical, Inc.LZG2025-07-11
10385084000106Omnipod Go Insulin Delivery Device 10U/day PODInsulet CorporationLZG2023-08-18
10385084000151Omnipod Go Insulin Delivery Device 15U/dayInsulet CorporationLZG2023-08-18
10385084000205Omnipod Go Insulin Delivery Device 20U/dayInsulet CorporationLZG2023-08-18
10385084000250Omnipod Go Insulin Delivery Device 25U/dayInsulet CorporationLZG2023-08-18
10385084000304Omnipod Go Insulin Delivery Device 30U/dayInsulet CorporationLZG2023-08-18
10385084000359Omnipod Go Insulin Delivery Device 35U/dayInsulet CorporationLZG2023-08-18
10385084000403Omnipod Go Insulin Delivery Device 40U/dayInsulet CorporationLZG2023-08-18
20385084000103Omnipod Go Insulin Delivery Device 10U/day PODINSULET CORPORATIONLZG2023-08-18
20385084000158Omnipod Go Insulin Delivery Device 15U/dayINSULET CORPORATIONLZG2023-08-18
20385084000202Omnipod Go Insulin Delivery Device 20U/dayINSULET CORPORATIONLZG2023-08-18
20385084000257Omnipod Go Insulin Delivery Device 25U/dayINSULET CORPORATIONLZG2023-08-18