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.

• 10848956007325 - Decontam Exam Gloves: 2025-01-08 S DECONTAM EXAM GLOVE - 14MIL
• 10848956007332 - Decontam Exam Gloves: 2025-01-08 M DECONTAM EXAM GLOVE - 14MIL
• 10848956007349 - Decontam Exam Gloves: 2025-01-08
• 10848956007356 - Decontam Exam Gloves: 2025-01-08
• 10848956007363 - Ultra Long Decontam Exam Gloves: 2025-01-08
• 10848956007370 - Ultra Long Decontam Exam Gloves: 2025-01-08
• 10848956007387 - Ultra Long Decontam Exam Gloves: 2025-01-08
• 10848956007394 - Ultra Long Decontam Exam Gloves: 2025-01-08