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V8800 Critical Care Ventilator

FDA UDI

Class II (US FDA UDI)

by Oricare Inc.

Identity

Trade Name
V8800 Critical Care Ventilator FDA UDI
Generic Name
Neonatal/adult intensive-care ventilator FDA UDI
Device Name
Critical Care Ventilator with standard features: Turkish Language. Europe Power Setup FDA UDI
Model / Reference
V8800 FDA UDI
Description
Critical Care Ventilator with standard features: Turkish Language. Europe Power Setup FDA UDI

Identifiers

Primary DI / UDI-DI
00815085020443 FDA UDI
510(k) Number
K120931 FDA UDI
FDA Product Code
CCK FDA UDI
CBK FDA UDI
BTI FDA UDI
BTT FDA UDI
GMDN Term
Neonatal/adult intensive-care ventilator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1400 FDA UDI
868.5895 FDA UDI
868.6250 FDA UDI
868.5450 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Neonatal/adult intensive-care ventilator

V8800 Critical Care Ventilator by Oricare Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neonatal/adult intensive-care ventilator.

Cleared under the same submission

K120931 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oricare Inc.

Sources (1)

  • FDA UDI c0668e20-4059-4ccc-99c5-99929e92ece7 36 fields · synced May 30, 2026