Identity
- Trade Name
- PATIENT CIRCUITS FDA UDI
- Generic Name
- Transport electric ventilator FDA UDI
- Device Name
- MASK, QUADRALITE, MEDIUM ADULT, ANAESTHETIC WITH YELLOW CUSHION AND HOOK RING, 22F (10/CASE) FDA UDI
- Model / Reference
- 712-000007-10 FDA UDI
- Description
- MASK, QUADRALITE, MEDIUM ADULT, ANAESTHETIC WITH YELLOW CUSHION AND HOOK RING, 22F (10/CASE) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847946024420 FDA UDI
- 510(k) Number
- K111473 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Transport electric ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
MR Safe FDA UDI
Category: Transport electric ventilator
Patient Circuits by Zoll Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transport electric ventilator.
- Life Support Products — Allied Medical LLC · Class II
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
- Pneupac — ICU MEDICAL, INC. · Class II
- Life Support Products — Allied Medical LLC · Class II
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
- Continuous Ventilator — FLIGHT MEDICAL INNOVATIONS LTD · Class II
Cleared under the same submission
K111473 also covers:
- AGILE TEST — Zoll Medical Corporation
- AGILE TEST — Zoll Medical Corporation
- Model AEV (Tan, Commercial) — Zoll Medical Corporation
- Model AEV (Tan, Commercial) — Zoll Medical Corporation
- Model AEV (Tan, Commercial) — Zoll Medical Corporation
- Model EMV+ Vent, Army, COMMERCIAL — Zoll Medical Corporation
- Model EMV+ Vent, Army, MRI — Zoll Medical Corporation
- Model EMV+ Vent, Army, MRI — Zoll Medical Corporation
- Model EMV+ Vent, Army, MRI — Zoll Medical Corporation
- Model EMV+ Vent, Army, MRI — Zoll Medical Corporation
- Model EMV+, Comm, MRI — Zoll Medical Corporation
- Model Eagle II — Zoll Medical Corporation
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 II | Pending data |
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Manufacturer
- Manufacturer
- Zoll Medical Corporation
Sources (1)
- FDA UDI 0db8b233-8047-4dcd-9fb1-66f00e034a49 35 fields · synced Jun 8, 2026