Bolin Chest Seal BCS01

GUDID M689BCS01040

1 ea - Valved Hydrogel Dressing / 1 ea - Gauze Pad INTENDED USE: FOR THE INITIAL MANAGEMENT OF PENETRATING CHEST INJURIES

Safeguard US Operating, LLC

Pneumothorax dressing

• Primary Device ID: M689BCS01040
• NIH Device Record Key: 91e907df-b80e-49a7-8803-3d55dc50cd2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bolin Chest Seal
• Version Model Number: 04
• Catalog Number: BCS01
• Company DUNS: 118492643
• Company Name: Safeguard US Operating, LLC
• Device Count: 1
• 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: false
• 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: true

Customer Support Contacts

• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com
• Phone: 855-428-6074
• Email: fulfillment@combatmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M689BCS01040 [Primary]

FDA Product Code

• NAD: Dressing, Wound, Occlusive

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: 2023-10-13
• Device Publish Date: 2023-10-05

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