TEC 7

GUDID 00840682111317

DATEX-OHMEDA INC

Sevoflurane anaesthesia vaporizer
Primary Device ID00840682111317
NIH Device Record Key62543195-c383-49da-b8e9-f8a7ea60f289
Commercial Distribution StatusIn Commercial Distribution
Brand NameTEC 7
Version Model NumberVAP SEV 8% EASY-FIL EN
Company DUNS129501685
Company NameDATEX-OHMEDA INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)345-2700
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682111317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CADVAPORIZER, ANESTHESIA, NON-HEATED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-01

On-Brand Devices [TEC 7]

00840682111454VAP SEV 8% EASY-FIL EN P1
00840682111393VAP ISO 5% EASY-FIL ES LATIN AMERICA
00840682111003VAP HAL 5% EASY-FIL EN
00840682111300VAP ISO 5% EASY-FIL EN
00840682111751VAP SEV 8% QUIK-FIL EN
00840682111744VAP SEV 8% EASY-FIL EN B1
00840682111614VAP SEV 8% EASY-FIL EN A1
00840682111508VAP SEV 8% EASY-FIL ES LATIN AMERICA
00840682111324VAP HAL 5% EASY-FIL ES LATIN AMERICA
00840682111317VAP SEV 8% EASY-FIL EN

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