FDA.reportPublic FDA data

HumaPen® Luxura™ HD - SAMPLE

Primary DI
00300029675013
Brand
HumaPen® Luxura™ HD - SAMPLE
Company
ELI LILLY AND COMPANY
Model
MS9675
Catalog number
MS9675
Device description
HumaPen Luxura HD is a reusable pen injector intended for use with Lilly 3 mL insulin cartridges. Designated for sample use.
Published
2017-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100988000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100988000HUMAPEN LUXURA HDEli Lilly and Company2010-08-17FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30300029675014PackageGS125In Commercial Distribution
00300029675013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3030002967501430300029675014
00300029675013003000296750133000296750130300029675013

GMDN Terms#

Term, Definition table
TermDefinition
Empty self-injector, 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 or carer for subcutaneous or intramuscular injection of a dose of the pharmaceutical agent via a replaceable needle. A dial on the injector is operated for dosing (e.g., via a spring-loaded mechanism). This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-800-545-5979xxx@xxx.xxx

Regulatory Flags#

DUNS number
006421325
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00300021151553Tempo Refill KitMC0002MC0002001AM2023-08-28
00300020948550Tempo Welcome KitMS9841MS9841001AM2022-11-01
00300020911554Tempo Smart ButtonMS6303MS63032022-11-01
30300020948551Tempo Welcome KitMS9841MS9841001AM2022-11-01
00300021451554Lilly TogetherMA9142 IOS (Version 17)MA9142001AM2025-04-17
00300021458553Lilly TogetherMA9141 Android (Version 17)MA9141001AM2025-04-17
00300021285555Lilly TogetherMA9161 Android (Version 15)MA9161001AM2024-11-26
00300021286552Lilly TogetherMA9162 IOS (Version 15)MA9162001AM2024-11-26
00300021283551Lilly TogetherMA9159 Android (Version 14)MA9159001AM2024-07-26
00300021284558Lilly TogetherMA9160 IOS (Version 14)MA9160001AM2024-07-26
00300021176556Lilly TogetherMA9152 Android (Version 13)MA9152001AM2024-03-11
00300021177553Lilly TogetherMA9158 IOS (Version 13)MA9158001AM2024-03-11
00300021174552Lilly TogetherMA9135 ANDROID (Version 12) MA9135001AM2024-02-16
00300021175559Lilly TogetherMA9140 IOS (Version 12)MA9140001AM2024-02-16
00300021107550Lilly TogetherMA7723 IOSMA7723001AM2022-10-25
00300021109554Lilly TogetherMA9131 AndroidMA9131001AM2022-10-25
00300020947553Tempo Refill KitMS9599MS9599001AM2022-11-01
00300029561019HumatroPen® 12 mg MS9561MS95612019-09-16
00300029562016HumatroPen® 24 mg MS9562MS95622019-09-16
00300029560012HumatroPen® 6 mgMS9560MS95602019-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02