FDA UDI
In Commercial Distribution
🇺🇸 United States
Bionostic, Inc.
DI: 00819601025240
·
Model: Calibration Gas
·
Airgas Therapeutics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bionostic, Inc.
- Primary DI
- 00819601025240
- Version / Model
- Calibration Gas
- Catalog Number
- AI MDG300
- Company Name
- Airgas Therapeutics, LLC
- Labeler DUNS
- 118537769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-08
- Public Version
- 1
- Public Version Date
- 2023-07-17
- Public Version Status
- New
- Public Device Record Key
- 1076a410-fe90-40ba-a030-dde0c80d0e60
Device Description
Description: MEDICAL AIR; Cylinder: 300; Valve: CGA 346; For calibration of medical analyzers in accordance with manufacturer's instructions. NOT FOR INHALATION
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 |
|---|---|---|---|---|
| 65332 | Calibration gas/refillable cylinder | A gas or custom mix of gases (e.g., CO2, O2, N2) in a dedicated, refillable, 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. The cylinder is filled with gas when delivered from the gas supplier. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819601025240 | GS1 |
Customer Contacts
- Phone
- 1-800-233-4334
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Pressure | 2400 | Pound per Square Inch | |
| Total Volume | 8000 | Liter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 52 Degrees Celsius