FDA UDI
In Commercial Distribution
🇺🇸 United States
PRIMO
DI: 00840216125964
·
Model: AFOPUMP
·
Asp Global, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PRIMO
- Primary DI
- 00840216125964
- Version / Model
- AFOPUMP
- Company Name
- Asp Global, LLC
- Labeler DUNS
- 080361159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-01
- Public Version
- 2
- Public Version Date
- 2024-09-19
- Public Version Status
- Update
- Public Device Record Key
- 2d024053-dbc7-41bc-8b05-eacbef19ba68
Device Description
PUMP, AIRFLOAT OVERLAY, GREY, 20EA/CS
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FMP | Protector, Skin Pressure | General Hospital | 880.6450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37883 | General positive-pressure manual hand inflator | A hand-operated manual device designed to draw in ambient air and expel the air from a connected nozzle to inflate a device (e.g., mattress, patient head support rings); it is not intended to be used with invasive devices. It is typically designed as a bicycle pump, a stirrup pump, or a large syringe-like pump, and is designed for use in the home and healthcare facilities. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840216125964 | GS1 |