FDA UDI
In Commercial Distribution
🇺🇸 United States
Drive
DI: 00822383982946
·
Model: BA9600-PUMP
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Drive
- Primary DI
- 00822383982946
- Version / Model
- BA9600-PUMP
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-16
- Public Version
- 2
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- 4131c88c-3dda-4cf3-9c9a-1c474969bde0
Device Description
PumpOnly W/Connectors, BA9600 Series,1e
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| FNM | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE | General Hospital | 880.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36688 | Alternating-pressure pump | An electrically-powered device that forces ambient air into the parallel chambers of an alternating-pressure bed mattress overlay or an alternating-pressure chair cushion, for the timed alternation of chamber inflation and thereby exchange of patient contact points. The pump, which may be programmable, ensures a regular exchange of the overlay/cushion pressure points for the patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10822383982943 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00822383982946 | GS1 |