FDA UDI
In Commercial Distribution
🇺🇸 United States
Scott Medical Products
DI: 00819601021860
·
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
- 00819601021860
- Version / Model
- Calibration Gas
- Catalog Number
- Z02NI354ED0000
- Company Name
- AIRGAS USA LLC
- Labeler DUNS
- 831996595
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-10
- Public Version
- 1
- Public Version Date
- 2020-05-18
- Public Version Status
- New
- Public Device Record Key
- 8e31adb4-1e3e-412f-891d-259da53cc409
Device Description
Description: 65% N2O, BAL. N2; Cylinder: ED; Valve: CGA 973; 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 |
|---|---|---|---|---|
| 35933 | Multiple blood gas analyte IVD, calibrator | A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819601021860 | GS1 |
Customer Contacts
- Phone
- 1-800-233-4334
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Pressure | 748 | Pound per Square Inch | |
| Total Volume | 233 | Liter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 52 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – Degrees Celsius