FDA.reportPublic FDA data

HumatroPen® 12 mg

Primary DI
00300029561019
Brand
HumatroPen® 12 mg
Company
ELI LILLY AND COMPANY
Model
MS9561
Catalog number
MS9561
Device description
HumatroPen 12 mg is a reusable pen injector intended for use with Humatrope 12 mg cartridges
Published
2019-09-16
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30300029561010PackageGS120In Commercial Distribution
00300029561019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3030002956101030300029561010
00300029561019003000295610193000295610190300029561019

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
800-545-5979xxx@xxx.xxx

Regulatory Flags#

DUNS number
006421325
Device count
1
Lot or batch
true
Expiration date on label
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
00300029562016HumatroPen® 24 mg MS9562MS95622019-09-16
00300029675013HumaPen® Luxura™ HD - SAMPLEMS9675MS96752017-05-25
00300029560012HumatroPen® 6 mgMS9560MS95602019-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579FD-1029NS - 10ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593FD-1054NS - 10ml PC Syringe - Nitro Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753609FD-1039NS - 10ml PC Syringe - Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616FD-1071NS - 10ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623FD-1028NS - 10ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647FD-1072NS - 10ml PC Syringe Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654FD-1030NS - 10ml PC Syringe - Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661FD-1042NS - 10ml PC Syringe - Contrast Print - Light Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678FD-1044NS - 10ml PC Syringe - Contrast Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753685FD-1045NS - 10ml PC Syringe - Contrast Print - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753692FD-1046NS - 10ml PC Syringe Contrast Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753708FD-1047NS - 10ml PC Syringe - Lidocaine Print - Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753715FD-1103NS - 20ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753722FD-1027NS - 10ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753753FD-1067NS - 3ml PC Syringe - Nitro Print - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753760FD-1038NS - 10ml PC Syringe Heparin Print Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01