FDA.reportPublic FDA data

Tenacore

Primary DI
00861269000213
Brand
Tenacore
Company
TENACORE HOLDINGS, INC.
Model
1
Device description
Low flow Oxygen blender
Published
2015-09-24
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
BZRMixer, Breathing Gases, Anesthesia Inhalation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081335000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081335000TENACORE OXYGEN BLENDER, MODEL TB-2000Tenacore Holdings, Inc.2008-11-14BZR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10861269000210PackageGS11In Commercial Distribution
00861269000213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086126900021010861269000210
00861269000213008612690002138612690002130861269000213

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen/air breathing gas mixer, hospitalAn independent mechanical device designed for accurate mixing of air and oxygen (O2) with O2 concentrations ranging from 21% to 100% (oxygen/air proportioner) that are appropriated for breathing in patients who need a concentration of O2 above the normal concentration in air. The mixer receives air and oxygen from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. The mixer may deliver the gas to the patient through devices such as ventilators, tracheostomy tubes, endotracheal (ET) tubes, oxygen tents, and/or masks.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
138781799
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852189007000TenacoreTFCT-PH06-23032016-10-17
00852189007017TenacoreTFCT-PH05-23032016-09-29
00852189007024TenacoreTFCT-CM03-02012016-10-17
00852189007031Tenacore TFCT-CM03-01012016-10-17
00852189007048TenacoreTFCT-CM02-01012016-10-17
00852189007055TenacoreTFCU-PH06-23032016-09-29
00852189007086TenacoreTFCU-CM03-02012016-10-18
00852189007093TenacoreTFCU-CM03-01012016-10-18
00852189007109TenacoreTFCU-CM02-01012016-09-29
00852189007147TenacoreTFCU-CM01-21012016-10-18
00852189007062Veevo1500 Series2016-09-29
00852189007079TenacoreTFCU-PH05-23032016-10-18
00852189007116Veevo3000 Series2016-09-29
00852189007123Veevo1510 Series2016-09-29
00852189007130Veevo1520 series2016-09-29
00852189007154Veevo7000 Series2016-09-29
00861269000237Veevo800 Series2016-09-29
00861269000282Veevo810 Series2016-09-29
00861269000299Veevo820 Series2016-09-29
00861269000206Tenacore12015-09-24

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