FDA UDI
In Commercial Distribution
🇺🇸 United States
BPR Medical
DI: 05060274501257
·
Model: Range A 0.02 - 3 l/min - DISS/Barb
·
BPR MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BPR Medical
- Primary DI
- 05060274501257
- Version / Model
- Range A 0.02 - 3 l/min - DISS/Barb
- Catalog Number
- 816-0032
- Company Name
- BPR MEDICAL LIMITED
- Labeler DUNS
- 236040130
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-07
- Public Version
- 1
- Public Version Date
- 2023-06-15
- Public Version Status
- New
- Public Device Record Key
- baec50b3-a4b5-4c2c-9fdd-4eeda1bc9fae
Device Description
Microdial Flowmeter - Range A 0.02 - 3 l/min - DISS/Barb. Provides a controlled flow of medicinal oxygen for the treatment of acute or chronic hypoxia.
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
- 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
- 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 |
|---|---|---|---|---|
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | Anesthesiology | 868.2340 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61366 | Medical gas flowmeter, dial-type | A device intended to regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It has a pre-calibrated adjustable flow selection dial intended to control the gas flow rate; it is not intended to provide flow rate measurements. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060274501257 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius