FDA UDI
In Commercial Distribution
🇺🇸 United States
Infant Flow SiPAP
DI: 10190752164864
·
Model: 27420-001
·
VYAIRE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Infant Flow SiPAP
- Primary DI
- 10190752164864
- Version / Model
- 27420-001
- Catalog Number
- 27420-001
- Company Name
- VYAIRE MEDICAL, INC.
- Labeler DUNS
- 080456871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-09
- Public Version
- 1
- Public Version Date
- 2021-03-17
- Public Version Status
- New
- Public Device Record Key
- d22e20d4-1056-46a8-9483-0a34c2f68b17
Device Description
KIT,SIPAP,IF,COMP,AUX,MDISS,ENGLISH
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | Anesthesiology | 868.5905 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14361 | Neonatal intensive-care ventilator | A mains electricity (AC-powered) automatic cycling device intended for short-term and long-term ventilatory support for a neonatal/paediatric patient, especially those preterm and critically ill with respiratory failure in a critical care setting. It is typically a time-cycled, pressure-control device that includes a small bore flexible tube breathing system. It may be capable of high frequency oscillatory ventilation in addition to conventional ventilation, and includes positive end-expiratory pressure (PEEP) and continuous positive airway pressure (CPAP) controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10190752164864 | GS1 |
Customer Contacts
- Phone
- +1(833)327-3284
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031745 | 000 |