Endoscope Brushes EBR-374-3770

GUDID 00848956001388

HEALTHMARK INDUSTRIES CO., INC.

Surgical instrument/endoscope cleaning brush/tool, single-use
Primary Device ID00848956001388
NIH Device Record Key62917af3-5568-40f0-9a4c-027bc9524a78
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoscope Brushes
Version Model NumberEBR-374-3770
Catalog NumberEBR-374-3770
Company DUNS057680480
Company NameHEALTHMARK INDUSTRIES CO., INC.
Device Count12
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100848956001388 [Unit of Use]
GS110848956001385 [Primary]

FDA Product Code

MNLAccessories, Cleaning Brushes, For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-02
Device Publish Date2020-09-24

On-Brand Devices [Endoscope Brushes]

00848956001449CC-374-3770
00848956001401STANDARD ENDOSCOPE BRUSH & VALVE BRUSH
00848956001395EBR-601
00848956001388EBR-374-3770
00848956001371EBR-374
00848956001364EBR-250-3770
00848956001357EBR-250
00848956001340EBR-172-3770
00848956001326EBR-172
00848956001319EBR-110-3770
00848956001265EBR-110
00848956001258CC-603-3770
00848956001241CC-603
00848956001227CC-230-900-3770
00848956001210CC-230-900
00848956001203CC-230-600-3770
00848956001197CC-230-600
00848956001180CC-230-400-3770
00848956001135CC-230-400

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.