FDA UDI
In Commercial Distribution
🇺🇸 United States
MedSource O2 Cylinder
DI: 00816703027288
·
Model: MS-SCYL-DT
·
MEDSOURCE INTERNATIONAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MedSource O2 Cylinder
- Primary DI
- 00816703027288
- Version / Model
- MS-SCYL-DT
- Catalog Number
- Not Applicable
- Company Name
- MEDSOURCE INTERNATIONAL LLC
- Labeler DUNS
- 041674552
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-11
- Public Version
- 1
- Public Version Date
- 2021-08-19
- Public Version Status
- New
- Public Device Record Key
- d7be839d-6252-4757-af7e-a3e71b48180b
Device Description
TANK, O2, D, Steel
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
- No
- 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 |
|---|---|---|---|---|
| 65331 | Calibration gas/non-refillable cylinder | A gas or custom mix of gases (e.g., CO2, O2, N2) in a dedicated, cylindrical container intended to calibrate a medical device (e.g., anaesthesia unit, blood gas analyte, patient monitor) to verify that it measures, displays and/or supplies the proper gas type, concentration and/or quantity; it may in addition be used for testing a patient’s pulmonary function. This device is reusable until the contents of the container are exhausted. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816703027288 | GS1 |