FDA UDI
In Commercial Distribution
🇺🇸 United States
Airgas Healthcare
DI: 00819601020023
·
Model: Device Gas
·
AIRGAS USA LLC
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Airgas Healthcare
- Primary DI
- 00819601020023
- Version / Model
- Device Gas
- Catalog Number
- Blood Gas
- Company Name
- AIRGAS USA LLC
- Labeler DUNS
- 831996595
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-01
- Public Version
- 1
- Public Version Date
- 2018-09-03
- Public Version Status
- New
- Public Device Record Key
- 3ae506a2-344c-4664-8f02-a805bf5b5bc7
Device Description
For calibration of Blood Gas Analyzers in accordance with Manufacturers Instruction.
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
- No
- 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 |
|---|---|---|---|---|
| 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 |
| 56671 | Blood gas analyser IVD, point-of-care | A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the calculation of other blood gas parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient] in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819601020023 | GS1 |
Customer Contacts
- Phone
- 866-935-3370
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 52 Degrees Celsius