Identity
- Trade Name
- 3100A HFOV FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- 3100A DISPOSABLES SHIP KIT (RIGID CIRCUIT) FDA UDI
- Model / Reference
- 770630-101 FDA UDI
- Description
- 3100A DISPOSABLES SHIP KIT (RIGID CIRCUIT) FDA UDI
Identifiers
- Catalog Number
- 770630-101 FDA UDI
- Primary DI / UDI-DI
- 10190752201576 FDA UDI
- PMA Number
- P890057 FDA UDI
- FDA Product Code
- LSZ FDA UDI
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ventilator breathing circuit, single-useRespiratory gas heating wire, adult
3100a Hfov by Vyaire Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Respiratory gas heating wire, adult.
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Cleared under the same submission
P890057 also covers:
- 3100 — VYAIRE MEDICAL, INC.
- 3100 HFOV — VYAIRE MEDICAL, INC.
- 3100 HFOV — VYAIRE MEDICAL, INC.
- 3100 HFOV — VYAIRE MEDICAL, INC.
- 3100 HFOV — VYAIRE MEDICAL, INC.
- 3100 HFOV — VYAIRE MEDICAL, INC.
- 3100A HFOV — VYAIRE MEDICAL, INC.
- 3100A HFOV — VYAIRE MEDICAL, INC.
- 3100A HFOV — VYAIRE MEDICAL, INC.
- 3100A HFOV — VYAIRE MEDICAL, INC.
- 3100A HFOV — VYAIRE MEDICAL, INC.
- 3100A HFOV — VYAIRE MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Vyaire Medical, Inc.
Sources (1)
- FDA UDI ed3a9af5-bd4e-4179-9d69-07d426aa19f2 36 fields · synced May 30, 2026