FDA.reportPublic FDA data

TRACOE® care

Primary DI
04035324012176
Brand
TRACOE® care
Company
Tracoe medical GmbH
Model
REF 938-A
Device description
TRACOE cleaning brushes with wool tip
Published
2016-03-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EPEBRUSH, CLEANING, TRACHEAL TUBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPEBrush, Cleaning, Tracheal TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035324012176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035324012176040353240121764035324012176

GMDN Terms#

Term, Definition table
TermDefinition
Airway device cleaning utensil, noninvasive, reusableA hand-held device intended to be used to clean an ex situ non-endoscopic airway device [e.g., endotracheal (ET) tube, tracheoesophageal speech valve, laryngeal airway], once it has been removed from the patient, to remove organic matter (e.g., phlegm). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a reusable device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
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
04035324001316TRACOE® comfortREF 102-032017-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904428744954OSSEOUS- Tube Cleaning Brush - 8mmEON MEDITECH PRIVATE LIMITEDEPE2026-03-13
08904428798483OSSEOUS- Tube Cleaning Brush - 8mmEON MEDITECH PRIVATE LIMITEDEPE2026-03-13
07331791011412Provox Swab SmallAtos Medical ABEPE2025-10-24
07331791011429Provox Swab MediumAtos Medical ABEPE2025-10-24
07331791011436Provox Swab LargeAtos Medical ABEPE2025-10-24
07331791012730Provox Swab XtraLargeAtos Medical ABEPE2025-10-24
00848530085414CPAP Cleaning KitSUNSET HEALTHCARE SOLUTIONS, INC.EPE2025-04-14
00848253004013Cleaning Brush, StandardFreudenberg Medical, LLCEPE2025-03-25
00848253004020Cleaning Brush, LongFreudenberg Medical, LLCEPE2025-03-25
00348783005110Premier Tracheal Tube BrushPREMIER DENTAL PRODUCTS COMPANYEPE2024-08-06
00348783005127Premier Tracheal Tube BrushPREMIER DENTAL PRODUCTS COMPANYEPE2024-08-06
00848530085407CPAP TubingSUNSET HEALTHCARE SOLUTIONS, INC.EPE2024-06-19
00630094174044Bioseal Inc.BIOSEALEPE2023-09-18
00630094174099Bioseal Inc.BIOSEALEPE2023-09-18
10630094174041Bioseal Inc.BIOSEALEPE2023-09-18
10630094174096Bioseal Inc.BIOSEALEPE2023-09-18
07331791002656Provox TubeBrush 8 mmAtos Medical ABEPE2022-11-25
07331791002663Provox TubeBrush 12 mmAtos Medical ABEPE2022-11-25
07331791016493Provox TubeBrush 8 mmAtos Medical ABEPE2022-11-25
07331791016509Provox TubeBrush 12 mmAtos Medical ABEPE2022-11-25
14063107102674Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
14063107102681Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
14063107102698Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
14063107102704Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
34063107102678Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
34063107102685Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
34063107102692Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
34063107102708Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
10080196466863ML-CANADAMEDLINE INDUSTRIES, INC.EPE2022-01-01
00653160004755CenturionCENTURION MEDICAL PRODUCTS CORPORATIONEPE2022-01-01