FDA.reportPublic FDA data

TRACOE mini

Primary DI
04035324019069
Brand
TRACOE mini
Company
Tracoe medical GmbH
Model
REF 356
Catalog number
REF 356
Device description
TRACOE® mini Extension Piece
Published
2015-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZACONNECTOR, AIRWAY (EXTENSION)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035324019069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035324019069040353240190694035324019069

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostoma device adaptor, single-useA noninvasive device intended to be used in the home and clinical settings by a person breathing through a tracheostoma to facilitate the connection of a device at the tracheostoma, on the skin side [e.g., heat and moisture exchanger (HME), oxygen administration cannula]. It is typically in the form of a ring or shallow hollow cylinder; some types have an integrated port to enable connection to respiratory gas tubing. It is not a tracheostomy mask (i.e., does not create a semi-tight enclosure around the tracheostoma). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49613691690info@tracoe.com

Regulatory Flags#

DUNS number
319414785
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035324012176TRACOE® careREF 938-A2016-03-15
04035324012183TRACOE® careREF 938-B2016-03-15
04035324012190TRACOE® careREF 938-C2016-03-15
04035324012220TRACOE® careREF 940-A2016-03-15
04035324012237TRACOE® careREF 940-B2016-03-15
04035324012244TRACOE® careREF 940-C2016-03-15
04035324012251TRACOE® careREF 940-D2016-03-15
04035324014927TRACOE® careREF 903-H-P2016-03-15
04035324014934TRACOE® careREF 903-I-P2016-03-15
04035324014941TRACOE® careREF 903-J-P2016-03-15
04035324014989TRACOE® careREF 903-H2015-10-24
04035324014996TRACOE® careREF 903-I2016-03-15
04035324015009TRACOE® careREF 903-J2016-03-15
04035324046812TRACOE® careREF 903-A2015-10-24
04035324047116TRACOE® careREF 903-D2015-10-24
04035324059812TRACOE® careREF 9362016-03-15
04035324059911TRACOE® careREF 9352016-03-15
04035324000111TRACOE® comfortREF 101-032017-07-01
04035324001118TRACOE® comfortREF 101-132017-07-01
04035324001217TRACOE® comfortREF 101-142017-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109721OXYGEN CONNECTOR/ADAPTERSunset Healthcare Solutions, Inc.BZA2026-09-09
00848530109820Ventilation AccessorySunset Healthcare Solutions, Inc.BZA2026-09-09
00848530109837Ventilation AccessorySunset Healthcare Solutions, Inc.BZA2026-09-09
06923980103629N/AGaleMed Xiamen Co., Ltd.BZA2026-07-28
06923980107672N/AGaleMed Xiamen Co., Ltd.BZA2026-07-28
06923980111969N/AGaleMed Xiamen Co., Ltd.BZA2026-07-28
04719874957551Create BiotechCREATE BIOTECH CO., LTD.BZA2026-07-21
04719874959197Create BiotechCREATE BIOTECH CO., LTD.BZA2026-07-21
05055931133858Reusable Angle Connector for CBS Bag Arm – Male to MaleFLEXICARE MEDICAL LIMITEDBZA2026-07-21
05055931133865Reusable Angle Connector for CBS Bag Arm – Male to FemaleFLEXICARE MEDICAL LIMITEDBZA2026-07-21
10197344012039HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-07-06
10197344214792HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-05-18
10197344009800HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-03-19
10197344012008HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012435HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012466HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012596HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344042326HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012473HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-12-12
00848530107925Tracheostomy and SuctionSunset Healthcare Solutions, Inc.BZA2025-12-09
00848530098261VENTILATOR ACCESSORYSunset Healthcare Solutions, Inc.BZA2025-08-28
00848530107246Oxygen Connector/AdapterSunset Healthcare Solutions, Inc.BZA2025-08-19
10197344042432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-08-18
10884521854147DARCovidien LPBZA2025-08-10
00848530106317Ventilator CircuitSunset Healthcare Solutions, Inc.BZA2025-07-15
00848530106324Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530106331Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530106348Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530060299Oxygen Connector/AdapterSunset Healthcare Solutions, Inc.BZA2025-06-03
00848530097363Ventilator AccessorySunset Healthcare Solutions, Inc.BZA2025-05-21