FDA.reportPublic FDA data

Grafco

Primary DI
M36834131
Brand
Grafco
Company
GF HEALTH PRODUCTS, INC.
Model
3413
Catalog number
3413
Device description
FEEDING TUBE BRUSH 12/BX
Published
2021-05-10
Public version status
Update
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
M36834131PrimaryHIBCC0
M36834130Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning utensil, reusableA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. 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