← Back to catalogue

Tec 7

FDA UDI

Class II (US FDA UDI)

by Datex-Ohmeda Inc.

Identity

Trade Name
TEC 7 FDA UDI
Generic Name
Isoflurane anaesthesia vaporizer FDA UDI
Model / Reference
VAP ISO 5% EASY-FIL ES LATIN AMERICA FDA UDI

Identifiers

Primary DI / UDI-DI
00840682111393 FDA UDI
510(k) Number
K012924 FDA UDI
FDA Product Code
CAD FDA UDI
GMDN Term
Isoflurane anaesthesia vaporizer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5880 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

No

FDA UDI

Category: Isoflurane anaesthesia vaporizer

Tec 7 by Datex-Ohmeda Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Isoflurane anaesthesia vaporizer.

Cleared under the same submission

K012924 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Datex-Ohmeda Inc.

Sources (1)

  • FDA UDI 8dc9f759-efdd-4b82-af4b-ca6b4ddcb2e4 34 fields · synced May 30, 2026