FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DeVilbiss
DI: 00885304002963
·
Model: PD1000A-M6-RE
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DeVilbiss
- Primary DI
- 00885304002963
- Version / Model
- PD1000A-M6-RE
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-07
- Public Version
- 3
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- c61b6a7a-c455-4447-813d-9d24f9e94ac0
- Distribution End Date
- 2020-06-01
Device Description
Respiratory Conservers Product Description REBUILT PD1000A W/M6 CYL
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| NFB | Conserver, oxygen | Anesthesiology | 868.5905 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11744 | Respiratory gas flow timer | An electronic device intended to measure the length of time of gas circulation, typically compressed gases delivered at a fixed pressure through a section of conduit or pipe. This device usually consists of a housing containing the electronics and measuring device(s), an input and output port for circulation of the measured gas and an analogue or digital time display that shows the elapsed time in discrete intervals (e.g., 0.10 hours) up to several hours. It is mainly used to measure the time of respiratory gas delivery [e.g., compressed medical air or oxygen (O2)] during emergency, chronic pulmonary illness, or tests; some gas flow timers are combined with gas flowmeters. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00885304002963 | GS1 |