Sterile Bulb & Bladder

GUDID 00848956006178

HEALTHMARK INDUSTRIES CO., INC.

Endoscope inflation bulb

• Primary Device ID: 00848956006178
• NIH Device Record Key: 659e7203-f90e-402d-908f-72ff5b6e2c39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Bulb & Bladder
• Version Model Number: SBB-01-5
• Company DUNS: 057680480
• Company Name: HEALTHMARK INDUSTRIES CO., INC.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848956006178 [Unit of Use]
GS1	10848956006175 [Primary]

FDA Product Code

• FCY: Bulb, Inflation, For Endoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-04
• Device Publish Date: 2023-08-25

Devices Manufactured by HEALTHMARK INDUSTRIES CO., INC.

• 00848956006178 - Sterile Bulb & Bladder: 2023-09-04
• 00848956006178 - Sterile Bulb & Bladder: 2023-09-04
• 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