Genotropin Pen® 5
GUDID 10300134761929
A non-sterile, reusable pen injector designed to be used by a patient to subcutaneously inject human growth hormone using a replaceable Two-Chamber Cartridge (TCC) containing Genotropin growth hormone inserted into the device.
PFIZER INC.
Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical| Primary Device ID | 10300134761929 |
| NIH Device Record Key | 3d8005b0-4ead-4749-907d-b43921198ae2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Genotropin Pen® 5 |
| Version Model Number | F000116153 |
| Company DUNS | 829076566 |
| Company Name | PFIZER INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10300134761929 [Primary] |
FDA Product Code
| NSC | Injector, Pen |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-13 |
| Device Publish Date | 2019-09-05 |
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Trademark Results [Genotropin Pen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENOTROPIN PEN 74721741 not registered Dead/Abandoned |
Pharmacia Inc. 1995-08-28 |
 GENOTROPIN PEN 74710962 2033472 Live/Registered |
PFIZER HEALTH AB 1995-08-04 |
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