Sterile Bulb & Bladder

GUDID 00848956006178

HEALTHMARK INDUSTRIES CO., INC.

Endoscope inflation bulb
Primary Device ID00848956006178
NIH Device Record Key659e7203-f90e-402d-908f-72ff5b6e2c39
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile Bulb & Bladder
Version Model NumberSBB-01-5
Company DUNS057680480
Company NameHEALTHMARK INDUSTRIES CO., INC.
Device Count5
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848956006178 [Unit of Use]
GS110848956006175 [Primary]

FDA Product Code

FCYBulb, Inflation, For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-04
Device Publish Date2023-08-25

Devices Manufactured by HEALTHMARK INDUSTRIES CO., INC.

00848956006178 - Sterile Bulb & Bladder2023-09-04
00848956006178 - Sterile Bulb & Bladder2023-09-04
00848956004860 - Disposable Bulb & Bladder 2023-01-12
00848956004921 - Protech ™ Trays 2022-12-15
00848956004938 - Protech ™ Trays 2022-12-15
00848956004945 - Protech ™ Trays 2022-12-15
00848956004952 - Protech ™ Trays 2022-12-15
00848956004969 - Protech ™ Trays 2022-12-15
00848956004983 - Protech ™ Trays 2022-12-15 INSTRU-TRAY AERATED 6.625W X 10.125L - GREEN

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