FDA.reportPublic FDA data

TEC 7

Primary DI
00840682111393
Brand
TEC 7
Company
DATEX-OHMEDA INC
Model
VAP ISO 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

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
00840682111393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682111393008406821113938406821113930840682111393

GMDN Terms#

Term, Definition table
TermDefinition
Isoflurane anaesthesia vaporizerA device used to vaporize the anaesthetic agent isoflurane 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 Pressure56.66 KiloPascal106.66 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
129501685
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682119320Well Baby BassinetBN42016-07-29
00840682119337Well Baby BassinetBN72016-07-29
00840682119344Well Baby BassinetBN32016-07-29
00840682119375Well Baby BassinetBN12016-07-29
00840682119399Well Baby BassinetBN22016-07-29
00840682119429Well Baby BassinetBN62016-07-29
00840682119436Well Baby BassinetBN92016-07-29
00840682119467Well Baby BassinetBN82016-07-29
00840682119481Well Baby BassinetBN102016-07-29
00840682119498Well Baby BassinetBN52016-07-29
00840682102353Aestiva GS7900 2 vap art arm2015-09-23
00840682102261Aespire79002015-09-23
00840682102285AespireView2015-09-23
00840682102308Aestiva79002015-09-23
00840682102339AestivaMRI2015-09-23
00840682102360Aestiva GS7900 3 vap art arm2015-09-23
00840682145596Carestation 750A12023-04-04
00840682146425Carestation 750cA12023-04-04
00195278579157ET CONTROL OPTIONAISYS CS22022-07-21
00195278588128AisysCS2 WITH ET CONTROL2022-07-21

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