FDA.reportPublic FDA data

inpen™

Primary DI
00763000645281
Brand
inpen™
Company
COMPANION MEDICAL, INC.
Model
MMT-105EVNNWW
Published
2022-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
NDCCalculator, Drug Dose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
NDCCalculator, Drug DoseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201337000InPen SystemCompanion Medical, Inc.2020-06-18NDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000645281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000645281007630006452817630006452810763000645281

GMDN Terms#

Term, Definition table
TermDefinition
Cartridge-accepting autoinjector, mechanicalA portable, hand-held, mechanical device, typically in the form of a large pen, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient to subcutaneously inject a dose of the pharmaceutical agent via a replaceable needle. The cartridge is inserted into the device and typically a dial on the device is operated for dosing (e.g., via a spring-loaded mechanism); the cartridge is replaced once the pharmaceutical is exhausted. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
057594435
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10862088000313InPen Smart Insulin Delivery SystemLilly - BlueInPen-100EL-BL / MMT-105ELBL2017-05-01
10862088000320InPen Smart Insulin Delivery SystemLilly - GreyInPen-100EL-GY / MMT-105ELGY2017-05-01
10862088000337InPen Smart Insulin Delivery SystemLilly - PinkInPen-100EL-PK / MMT-105ELPK2017-05-01
10862088000344InPen Smart Insulin Delivery SystemNovo - BlueInPen-100NN-BL / MMT-105NNBL2017-05-01
10862088000351InPen Smart Insulin SystemNovo - GreyInPen-100NN-GY / MMT-105NNGY2017-05-01
10862088000368InPen Smart Insulin Delivery SystemNovo - PinkInPen-100NN-PK / MMT-105NNPK2017-05-01
00763000645298inpen™MMT-105EVELWW2022-08-08
62088-0000-31InPen Smart Insulin Delivery SystemLilly - BlueInPen-100EL-BL / MMT-105ELBL2017-05-01
62088-0000-32InPen Smart Insulin Delivery SystemLilly - GreyInPen-100EL-GY / MMT-105ELGY2017-05-01
62088-0000-33InPen Smart Insulin Delivery SystemLilly - PinkInPen-100EL-PK / MMT-105ELPK2017-05-01
62088-0000-34InPen Smart Insulin Delivery SystemNovo - BlueInPen-100NN-BL / MMT-105NNBL2017-05-01
62088-0000-35InPen Smart Insulin SystemNovo - GreyInPen-100NN-GY / MMT-105NNGY2017-05-01
62088-0000-36InPen Smart Insulin Delivery SystemNovo - PinkInPen-100NN-PK / MMT-105NNPK2017-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450487402Merit Medical®Merit Medical Systems, Inc.FMF2026-08-07
08800045103061Feel Ject(FIS-054, U-100, 1.0cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105164Feel Ject(FIS-202, U-100, 0.3 cc, 29G x 12.7mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
00810131885045ION Non CervicalSurgentec, LLCFMF2026-07-28
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02