FDA UDI
In Commercial Distribution
🇺🇸 United States
Vyaire
DI: 04250892906140
·
Model: 706596
·
Vyaire Medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vyaire
- Primary DI
- 04250892906140
- Version / Model
- 706596
- Catalog Number
- 706596
- Company Name
- Vyaire Medical GmbH
- Labeler DUNS
- 329769991
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-16
- Public Version
- 1
- Public Version Date
- 2021-07-26
- Public Version Status
- New
- Public Device Record Key
- a4dda9d2-d406-4e6b-8a69-a9577e44586a
Device Description
Calibration Syringe 3 Liter
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| BXW | Calibrator, Volume, Gas | Anesthesiology | 868.1870 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60343 | Gas volume reference standard | A manual instrument intended to deliver a precise, known quantity of gas (e.g., 1 litre) for the purposes of calibrating/testing a medical device partially or completely dedicated to measuring/monitoring volumes of air/gas (e.g., anaesthesia monitor, diagnostic spirometer). It is typically presented as a syringe-like device with a manually-operated plunger and may include appropriate connecting tubing. This device is intended to be used by a healthcare provider in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250892906140 | GS1 |
Customer Contacts
- Phone
- +499314972127
- [email protected]