FDA UDI
In Commercial Distribution
🇺🇸 United States
Oxygen Wrench
DI: 00628725097169
·
Model: VA-3040
·
Canadian Hospital Specialties Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Oxygen Wrench
- Primary DI
- 00628725097169
- Version / Model
- VA-3040
- Catalog Number
- VA-3040
- Company Name
- Canadian Hospital Specialties Limited
- Labeler DUNS
- 240992693
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-19
- Public Version
- 1
- Public Version Date
- 2024-07-29
- Public Version Status
- New
- Public Device Record Key
- ed9a1d0c-cd06-460c-8619-0d3a52c48ce5
Device Description
OXYGEN WRENCH
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60342 | Gas line connection reference standard | A reference standard device intended to represent one end of a medical quick-connect coupling or a terminal unit of a gas-specific format [e.g., oxygen (O2), nitrous oxide (N2O), medical air], which may be used to evaluate connection port compatibility and integrity. It is designed with specific gas and device type mechanical mating patterns whereby it may also be used to test the medical gas pipeline integrity (i.e., test for leakage). It may consist of both a male end (to test a female socket) and female end (to test a male plug). This device is intended to be used by a professional in a professional setting (e.g., clinical engineering). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628725097169 | GS1 | ||||
| Package | 50628725097164 | GS1 | Corrugate Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 9058259300
- [email protected]