FDA UDI
In Commercial Distribution
🇺🇸 United States
Scott Medical Products
DI: 00819601020429
·
Model: Calibration Gas
·
AIRGAS USA LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Scott Medical Products
- Primary DI
- 00819601020429
- Version / Model
- Calibration Gas
- Catalog Number
- Z02NI98M350Y050
- Company Name
- AIRGAS USA LLC
- Labeler DUNS
- 831996595
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-19
- Public Version
- 1
- Public Version Date
- 2019-08-27
- Public Version Status
- New
- Public Device Record Key
- 27cd1997-80c4-47b3-a11a-494036a431ee
Device Description
Description: 2% ENFLURANE, BAL. N2; Cylinder: XL; Valve: CGA 510; For calibration of medical analyzers in accordance with manufacturer's instructions.
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 |
|---|---|---|---|---|
| 35467 | Carbon monoxide breath analyser | An electronic device intended to be used in a clinical setting to measure the concentration of carbon monoxide (CO) in a gas-mixture sample, exhaled by a patient, using a particular method (e.g., electrochemical, infrared spectroscopy, gas chromatography). It may be used to aid in determining the patient's ventilatory status (typically the lung diffusing capacity), or for determining exhaled CO levels (e.g., during jaundice screening in newborns, or in smoking cessation programs); it may also have the capacity to measure the concentration of CO in the atmosphere. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819601020429 | GS1 |
Customer Contacts
- Phone
- 1-800-233-4334
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 54 | Liter | |
| Pressure | 398 | Pound per Square Inch |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- – 52 Degrees Celsius