FDA UDI
In Commercial Distribution
🇺🇸 United States
Glatopaject ®
DI: 57622436104114
·
Model: 49047024
·
AEROPHARM GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Glatopaject ®
- Primary DI
- 57622436104114
- Version / Model
- 49047024
- Catalog Number
- 49048215
- Company Name
- AEROPHARM GmbH
- Labeler DUNS
- 499181139
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-19
- Public Version
- 1
- Public Version Date
- 2025-08-27
- Public Version Status
- New
- Public Device Record Key
- 41f00046-9cfe-4397-b659-85c3e0d6394e
Device Description
The Glatopaject® is a reusable injection device for the subcutaneous injection of Glatopa®. The Glatopaject® is intended for use with Glatopa® (Glatiramer Acetate Injection) Pre-Filled Syringe.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KZH | Introducer, Syringe Needle | General Hospital | 880.6920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62117 | Syringe-loaded medication/vaccine injector, manual, home-use | A hand-held, manually-powered, mechanical device intended to be used in conjunction with an appropriate plunger syringe and needle for the self-administration of a medication or vaccine to a patient intramuscularly (IM) and/or subcutaneously; it is not intended for intradermal injection. It is typically a spring-loaded mechanical assembly intended to accept a prefilled syringe and needle; the syringe, needle and pharmaceutical are not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 47622436104100 | GS1 | ||||
| Primary | 57622436104114 | GS1 | ||||
| Previous | 57613421039603 | GS1 |
Customer Contacts
- Phone
- 1-800-525-8747
- [email protected]