Identity
- Trade Name
- 3100 HFOV FDA UDI
- Generic Name
- Inspiratory/expiratory limb respiratory tubing, reusable FDA UDI
- Device Name
- Tube Set, Filtered Patient Circuit FDA UDI
- Model / Reference
- 11438-PMN FDA UDI
- Description
- Tube Set, Filtered Patient Circuit FDA UDI
Identifiers
- Catalog Number
- 11438-PMN FDA UDI
- Primary DI / UDI-DI
- 10190752158900 FDA UDI
- PMA Number
- P890057 FDA UDI
- FDA Product Code
- LSZ FDA UDI
- GMDN Term
- Inspiratory/expiratory limb respiratory tubing, reusable 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Inspiratory/expiratory limb respiratory tubing, reusable
3100 Hfov by Vyaire Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inspiratory/expiratory limb respiratory tubing, reusable.
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- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
- CPAP Tubing — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- CPAP Kit — SUNSET HEALTHCARE SOLUTIONS, Inc.
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.
- 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.
- 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 29ffcbe6-382a-44f3-aea3-0d2a4bfa2d8a 36 fields · synced May 30, 2026