FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Scott Medical Products
DI: 00819601021235
·
Model: Calibration Gas
·
AIRGAS USA LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Scott Medical Products
- Primary DI
- 00819601021235
- Version / Model
- Calibration Gas
- Catalog Number
- Z04OX46MSDC002
- Company Name
- AIRGAS USA LLC
- Labeler DUNS
- 831996595
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-12
- Public Version
- 2
- Public Version Date
- 2023-06-21
- Public Version Status
- Update
- Public Device Record Key
- 4168633a-ed48-4d4c-a5b0-3d94b3f15756
- Distribution End Date
- 2023-06-20
Device Description
Description: 5% Desflurane, 5.5% CO2, 43% N2O, Bal. O2; Cylinder: SD; Valve: CGA 600; For calibration of medical analyzers in accordance with manufacturer's instructions. CE Marked
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
- 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 |
|---|---|---|---|---|
| BXK | Gas, Calibration (Specified Concentration) | Anesthesiology | 868.6400 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36892 | Ether anaesthesia vaporizer | A device used to vaporize the anaesthetic agent ether and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator, but some types may be used as stand-alone devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819601021235 | GS1 |
Customer Contacts
- Phone
- 1-800-233-4334
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 7.5 | Liter | |
| Pressure | 92 | Pound per Square Inch |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- – 52 Degrees Celsius