FDA.reportPublic FDA data

TEC 6 PLUS

Primary DI
00840682112536
Brand
TEC 6 PLUS
Company
DATEX-OHMEDA INC
Model
VAP DES 120V USA
Published
2016-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CADVAPORIZER, ANESTHESIA, NON-HEATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CADVaporizer, Anesthesia, Non-HeatedAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000275000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000275000DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIADatex-Ohmeda, Inc.2000-04-12CAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682112536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682112536008406821125368406821125360840682112536

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)345-2700xx@xx.xx

Regulatory Flags#

DUNS number
129501685
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682103947Carestation 650A12016-02-12
00840682103954Carestation 650cA12016-02-12
00840682103985Carestation 620A12016-02-12
00840682111317TEC 7VAP SEV 8% EASY-FIL EN2016-06-01
00840682111324TEC 7VAP HAL 5% EASY-FIL ES LATIN AMERICA2016-06-01
00840682111508TEC 7VAP SEV 8% EASY-FIL ES LATIN AMERICA2016-06-01
00840682111614TEC 7VAP SEV 8% EASY-FIL EN A12016-06-01
00840682111751TEC 7VAP SEV 8% QUIK-FIL EN2016-06-01
00840682112659TEC 6 PLUSVAP DES 220/240V EN2016-06-01
00840682123983Aladin2SEV CLOSED-FILL2018-02-27
00840682123990Aladin2SEV CLOSED-FILL2018-02-15
00840682124720TEC820 SEV2018-03-12
00840682124737TEC850 SEV2018-03-12
00840682124744TEC820 ISO2018-03-12
00840682124751TEC850 ISO2018-03-12
00840682134880NAABS ABSORBENT CANISTER REUSABLE2018-01-18
00840682111300TEC 7VAP ISO 5% EASY-FIL EN2016-06-01
00840682111003TEC 7VAP HAL 5% EASY-FIL EN2016-06-01
00840682111393TEC 7VAP ISO 5% EASY-FIL ES LATIN AMERICA2016-06-01
00840682100274Aladin2ENF EASY-FIL2015-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06903053055000V80 Anesthetic VaporizerShenzhen Mindray Bio-Medical Electronics Co., Ltd.CAD2026-01-08
05051977001465PenlonPENLON LTDCAD2024-12-06
05051977002011PenlonPENLON LTDCAD2024-12-06
05051977002028PenlonPENLON LTDCAD2024-12-06
05051977002035PenlonPENLON LTDCAD2024-12-06
05051977002042PenlonPENLON LTDCAD2024-12-06
05051977001595PenlonPENLON LTDCAD2023-06-21
B005003320AincA®ANESTHESIA ASSOCIATES, INC.CAD2021-03-31
00840682124720TECDATEX-OHMEDA INCCAD2018-03-12
00840682124737TECDATEX-OHMEDA INCCAD2018-03-12
00840682124744TECDATEX-OHMEDA INCCAD2018-03-12
00840682124751TECDATEX-OHMEDA INCCAD2018-03-12
10620974002038Quik FilSouthmedic IncorporatedCAD2018-02-23
05051977000314Key Filler Bottle Adaptor MRIPENLON LTDCAD2017-08-01
05051977000536PenlonPENLON LTDCAD2017-07-18
05051977000444PenlonPENLON LTDCAD2017-02-14
10841522118135Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118173Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118258Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118265Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118326Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118357Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118371Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118401Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522119323Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522106712Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118234Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522106774Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522106736Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522106750Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03