Disposable Bulb & Bladder D30200-210S

GUDID 00848956004860

HEALTHMARK INDUSTRIES CO., INC.

Endoscope inflation bulb

• Primary Device ID: 00848956004860
• NIH Device Record Key: 0af93a33-4600-4a8d-8d61-58826606ab26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Bulb & Bladder
• Version Model Number: D30200-210S
• Catalog Number: D30200-210S
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848956004860 [Unit of Use]
GS1	10848956004867 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-01-12
• Device Publish Date: 2022-12-08

Devices Manufactured by HEALTHMARK INDUSTRIES CO., INC.

• 00848956006178 - Sterile Bulb & Bladder: 2023-09-04
• 00848956004860 - Disposable Bulb & Bladder: 2023-01-12
• 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