FDA.reportPublic FDA data

TRACOE care

Primary DI
04035324060917
Brand
TRACOE care
Company
Tracoe medical GmbH
Model
REF 932
Catalog number
REF 932
Device description
TRACOE tube clean Cleaning powder
Published
2023-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGVTracheostomy Cleaning Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGVTracheostomy Cleaning TrayAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035324060917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035324060917040353240609174035324060917

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning agentA substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from rain. Keep away from sunlight.
Special Storage Condition, Specify00no special storage conditions

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

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
10197106992586CARDINAL HEALTHCardinal Health 200, LLCOGV2025-04-17
50197106992584CARDINAL HEALTHCardinal Health 200, LLCOGV2025-04-17
10197106916797CARDINAL HEALTHCardinal Health 200, LLCOGV2025-02-04
50197106916795CARDINAL HEALTHCardinal Health 200, LLCOGV2025-02-04
10080196141609MedlineMEDLINE INDUSTRIES, INC.OGV2023-12-21
40080196141600MedlineMEDLINE INDUSTRIES, INC.OGV2023-12-21
04035324061112TRACOE careTracoe medical GmbHOGV2023-06-17
10080196032877MedlineMEDLINE INDUSTRIES, INC.OGV2021-10-29
40080196032878MedlineMEDLINE INDUSTRIES, INC.OGV2021-10-29
10884389747445MedlineMEDLINE INDUSTRIES, INC.OGV2021-09-24
10888277012417MedlineMEDLINE INDUSTRIES, INC.OGV2021-09-24
40884389747446MedlineMEDLINE INDUSTRIES, INC.OGV2021-09-24
40888277012418MedlineMEDLINE INDUSTRIES, INC.OGV2021-09-24
10884389747421MedlineMEDLINE INDUSTRIES, INC.OGV2021-09-23
40884389747422MedlineMEDLINE INDUSTRIES, INC.OGV2021-09-23
10884389678091MedlineMEDLINE INDUSTRIES, INC.OGV2021-04-05
10884389934395MedlineMEDLINE INDUSTRIES, INC.OGV2021-04-05
10888277228306MedlineMEDLINE INDUSTRIES, INC.OGV2021-04-05
10888277597921MEDLINEMEDLINE INDUSTRIES, INC.OGV2021-04-05
40884389678092MedlineMEDLINE INDUSTRIES, INC.OGV2021-04-05
40884389934396MedlineMEDLINE INDUSTRIES, INC.OGV2021-04-05
40888277228307MedlineMEDLINE INDUSTRIES, INC.OGV2021-04-05
40888277597922MEDLINEMEDLINE INDUSTRIES, INC.OGV2021-04-05
10884389209561MEDLINEMEDLINE INDUSTRIES, INC.OGV2021-04-02
10884389297919MEDLINEMEDLINE INDUSTRIES, INC.OGV2021-04-02
10884389297933MedlineMEDLINE INDUSTRIES, INC.OGV2021-04-02
10884389386415MedlineMEDLINE INDUSTRIES, INC.OGV2021-04-02
10884389536629Medical Equipment AffiliatesMEDLINE INDUSTRIES, INC.OGV2021-04-02
10884389610619MEDLINEMEDLINE INDUSTRIES, INC.OGV2021-04-02
10884389657690MedlineMEDLINE INDUSTRIES, INC.OGV2021-04-02