FDA.reportPublic FDA data

FlexPro® PenMate®

Primary DI
00301697712901
Brand
FlexPro® PenMate®
Company
NOVO NORDISK INC.
Model
771290
Catalog number
771290
Device description
Auto-insertion accessory only for Norditropin® FlexPro® 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL prefilled pens. Designed and intended for use with Novo Nordisk® disposable needles.
Published
2019-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KZHIntroducer, Syringe Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZHIntroducer, Syringe NeedleGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30301697712902PackageGS16In Commercial Distribution
00301697712901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3030169771290230301697712902
00301697712901003016977129013016977129010301697712901

GMDN Terms#

Term, Definition table
TermDefinition
Self-injection aidA device designed to be used by a layperson to self-administer a subcutaneous injection, typically by a person who has difficulty with painless self-injections [e.g., patients with rheumatoid arthritis (RA)]. It is typically a small box or container in which a prefilled syringe assembly (syringe with medication and needle) is placed and secured; the user grips the container, places it on the body surface at the injection site, and presses the plunger of the syringe to inject the medication. The device enables needle penetration at an appropriate angle (typically 90? to the body surface) and to a pre-set depth. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-668-6444nnicustomercare@novonordisk.com
+18886686444nnicustomercare@novonordisk.com

Regulatory Flags#

DUNS number
012177531
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00301691851897NovoFine® 32G Tip1851891851892016-09-17
00301691851972NovoFine® 32G Tip1851971851972016-09-17
00301691852757NovoFine® Autocover® 30G1852751852752016-09-17
00301691854591NovoPen Echo®1854591854592016-11-23
00301691855505NovoFine® Plus 32G1855501855502016-09-17
00301691855918NovoFine® Plus 32G1855911855912016-09-17
00301691856502NovoFine® Plus 32G1856501856502017-12-06
00301691856519NovoFine® Plus 32G1856511856512017-12-06
00301691858506NovoFine® Plus 32G1858501858502017-12-06
00301691858513NovoFine® Plus 32G1858511858512017-12-06
00301697200064Administration Set7200067200062017-06-13
00301691852979NovoFine® Autocover® 30G1852971852972016-09-17
00301691852504NovoFine® 30G1852501852502016-09-17
30301691851898NovoFine® 32G Tip1851891851892016-09-17
30301691851973NovoFine® 32G Tip1851971851972016-09-17
30301691854592NovoPen Echo®1854591854592016-11-23
00301691853891NovoTwist® 32G1853891853892016-09-17
30301691852758NovoFine® Autocover® 30G1852751852752016-09-17
30301691852970NovoFine® Autocover® 30G1852971852972016-09-17
30301691853892NovoTwist® 32G1853891853892016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B33919800010V-CathNeo Medical Inc.KZH2026-03-27
05713495000121SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
05713495000138SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
57622436104114Glatopaject ®AEROPHARM GmbHKZH2025-08-19
47622436104100Glatopaject ®AEROPHARM GmbHKZH2025-08-19
00860010587317CoolJect Targeted-Mist 1-3cc Nook Syringe Holder AccessoryVapocoolshot, IncKZH2025-08-01
00850037806058Orbit InserterModular Medical, Inc.KZH2025-07-11
00850037806119MODD1 Starter KitModular Medical, Inc.KZH2025-07-11
00850037806126MODD1 Patient Welcome KitModular Medical, Inc.KZH2025-07-11
00370095000002GripMate™SUN PHARMACEUTICAL INDUSTRIES, INC.KZH2025-05-12
05714472000004Needle Guide AssistantUnion Medico ApSKZH2025-05-05
B33935290030NeoMagicNeo Medical Inc.KZH2025-01-22
B33935290035NeoMagicNEO MEDICAL INC.KZH2025-01-22
00860006961510Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncKZH2023-01-27
00860006961534Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncKZH2023-01-27
00817708022964AccuSertEMED TECHNOLOGIES CORPORATIONKZH2022-10-24
00817708022988AccuSertEMED TECHNOLOGIES CORPORATIONKZH2022-10-24
00643169705920Sil-serter™MEDTRONIC MINIMED, INC.KZH2022-09-17
00643169768086Minimed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2022-07-07
00763000573690MiniMed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2022-07-07
05713495000077Skytrofa Auto-InjectorPhillips-Medisize A/SKZH2021-10-22
05713495000084Skytrofa Auto-InjectorPhillips-Medisize A/SKZH2021-10-22
00763000381080Sil-serter™MEDTRONIC MINIMED, INC.KZH2021-04-22
00763000354817MiniMed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2020-06-14
05713495000015BETACONNECTPhillips-Medisize A/SKZH2019-10-07
00355513192019Onpro kitAMGEN INC.KZH2019-09-24
10355513192016Onpro kitAMGEN INC.KZH2019-09-24
00025294874007Inject-EaseAMBI, INC.KZH2018-12-17
57612799202398Extavia® Auto-Injector IINOVARTIS PHARMACEUTICALS CORPORATIONKZH2018-09-24
47612799202391Extavia® Auto-Injector IINOVARTIS PHARMACEUTICALS CORPORATIONKZH2018-09-24