FDA UDI
In Commercial Distribution
🇺🇸 United States
BPR Medical
DI: 05060274504234
·
Model: Firesafe Cannula Valve - Bidirectional Mk.2
·
BPR MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BPR Medical
- Primary DI
- 05060274504234
- Version / Model
- Firesafe Cannula Valve - Bidirectional Mk.2
- Catalog Number
- 827-2001
- 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
- b0e31471-b733-43ec-87be-792a2024f03f
Device Description
Firesafe Cannula Valve - Bidirectional Mk.2. The intended medical purpose is to act as part of a conduit assembly through which oxygen is delivered to patients during normobaric oxygen therapy. A further non-medical purpose is to extinguish a fire in oxygen therapy tubing and isolate the oxygen supply. The non-medical purpose is further described in the technical description below.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 60391 | Oxygen tubing fire safety valve | A safety device intended to be integrated into oxygen delivery tubing to automatically stop the flow of oxygen and isolate the oxygen supply in the event of a fire. It typically consists of a small two-way tubing connector containing a thermal fuse. This is a single-patient, reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 25060274504238 | GS1 | Bag | 20 | In Commercial Distribution | |
| Primary | 05060274504234 | GS1 | ||||
| Package | 35060274504235 | GS1 | Carton | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- +441623628281
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius