FDA UDI
In Commercial Distribution
🇺🇸 United States
Vital Signs™
DI: 10889483586822
·
Model: 5630M42
·
AIRLIFE
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Vital Signs™
- Primary DI
- 10889483586822
- Version / Model
- 5630M42
- Catalog Number
- 5630M42
- Company Name
- AIRLIFE
- Labeler DUNS
- 119058668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-27
- Public Version
- 2
- Public Version Date
- 2025-04-17
- Public Version Status
- Update
- Public Device Record Key
- e95e5361-1d04-4300-baff-0c035ee47be9
Device Description
Vital Signs™ Gas Sampling Interface
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45566 | Gas-sampling/monitoring respiratory tubing, single-use | A length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30889483586826 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 10889483586822 | GS1 | ||||
| Previous | 10190752146693 | GS1 |
Customer Contacts
- Phone
- (800)433-2797
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K840966 | 000 |