FDA.reportPublic FDA data

TEC 7

Primary DI
00840682111324
Brand
TEC 7
Company
DATEX-OHMEDA INC
Model
VAP HAL 5% EASY-FIL ES LATIN AMERICA
Device description
TEC 7 VAP HAL 5% EASY-FIL ES LATIN AMERICA
Published
2016-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K012924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012924000DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZERDatex-Ohmeda, Inc.2002-01-30CAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682111324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682111324008406821113248406821113240840682111324

GMDN Terms#

Term, Definition table
TermDefinition
Halothane anaesthesia vaporizerA device used to vaporize the anaesthetic agent halothane (also known as fluorothane) and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
129501685
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00840682102353Aestiva GS7900 2 vap art arm2015-09-23

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