FDA.reportPublic FDA data

Grafco

Primary DI
M368339921
Brand
Grafco
Company
GF HEALTH PRODUCTS, INC.
Model
3399-2
Catalog number
3399-2
Device description
"TRACH TUBE BRUSH 4-1/2"" F/00-4"
Published
2021-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
M368339921PrimaryHIBCC0
M368339920Unit of UseHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
770-368-4700cs@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
12
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368FR601EPCHBN04271LUMEXFR601EPCHBN-04272026-09-18
M368FR601EPCHBN96071LUMEXFR601EPCHBN-96072026-09-18
M368FR601EPCHNN04271LUMEXFR601EPCHNN-04272026-09-18
M368FR601EPCNBN04271LUMEXFR601EPCNBN-04272026-09-18
M368FR601EPCNNN04271LUMEXFR601EPCNNN-04272026-09-18
M368FR601EPCOBN04271LUMEXFR601EPCOBN-04272026-09-18
M368FR601EPCONN04271LUMEXFR601EPCONN-04272026-09-18
M368FR601EPNHBN04271LUMEXFR601EPNHBN-04272026-09-18
M368FR601EPNHNN04271LUMEXFR601EPNHNN-04272026-09-18
M368FR601EPNHNN86021LUMEXFR601EPNHNN-86022026-09-18
M368FR601EPNNBN04271LUMEXFR601EPNNBN-04272026-09-18
M368FR601EPNNBN86041LUMEXFR601EPNNBN-86042026-09-18
M368FR601EPNNNN03171LUMEXFR601EPNNNN-03172026-09-18
M368FR601EPNNNN04271LUMEXFR601EPNNNN-04272026-09-18
M368FR601EPNOBN04271LUMEXFR601EPNOBN-04272026-09-18
M368FR601EPNONN04271LUMEXFR601EPNONN-04272026-09-18
M368FR601EPNONN13111LUMEXFR601EPNONN-13112026-09-18
M368FR601EUCHBN04271LUMEXFR601EUCHBN-04272026-09-18
M368FR601EUCHNN04271LUMEXFR601EUCHNN-04272026-09-18
M368IN601EPCHBNCOM1INTENSAIN601EPCHBN-COM2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15019517382570ICU Medical, Inc.ICU MEDICAL, INC.EPE2026-06-25
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