FDA UDI
In Commercial Distribution
🇺🇸 United States
Pressure reducer O2,PININDEX,Primus
DI: 04048675290735
·
Model: 8603466
·
Drägerwerk AG & Co. KGaA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Pressure reducer O2,PININDEX,Primus
- Primary DI
- 04048675290735
- Version / Model
- 8603466
- Company Name
- Drägerwerk AG & Co. KGaA
- Labeler DUNS
- 315578914
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-29
- Public Version
- 1
- Public Version Date
- 2022-07-07
- Public Version Status
- New
- Public Device Record Key
- 62139d9f-74c3-48a0-8877-bec8a53c9a85
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| CAN | Regulator, Pressure, Gas Cylinder | Anesthesiology | 868.2700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31315 | Anaesthesia workstation yoke assembly | A device that is a module to an anaesthesia workstation and functions as a mounting system used to attach compressed gas cylinders to the anaesthesia system. The yoke assembly typically includes a filter, pressure regulator, pressure relief valve, and pressure indicator, or gas-specific pin-index connecting system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048675290735 | GS1 |