FDA.reportPublic FDA data

HumatroPen® 24 mg

Primary DI
30300029562017
Brand
HumatroPen® 24 mg
Company
ELI LILLY AND COMPANY
Model
MS9562
Catalog number
MS9562
Device description
HumatroPen 24 mg is a reusable pen injector intended for use with Humatrope 24 mg cartridges
Published
2019-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
30300029562017PackageGS120In Commercial Distribution
00300029562016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3030002956201730300029562017
00300029562016003000295620163000295620160300029562016

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

Contacts#

Phone, Email table
PhoneEmail
18005455979xxx@xxx.xxx

Regulatory Flags#

DUNS number
006421325
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00300029675013HumaPen® Luxura™ HD - SAMPLEMS9675MS96752017-05-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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