B-Cool Super Sling Universal (Sling Only)

GUDID 00610570191444

Bird & Cronin, LLC

Padded stays splint, single-use

• Primary Device ID: 00610570191444
• NIH Device Record Key: 4b52cb55-53ae-4c74-aa09-4a50254c838f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B-Cool Super Sling Universal (Sling Only)
• Version Model Number: 08148260
• Company DUNS: 045975349
• Company Name: Bird & Cronin, 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: false
• 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	00610570191444 [Primary]

FDA Product Code

• IQI: Orthosis, Limb Brace

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-24
• Device Publish Date: 2023-02-16

Devices Manufactured by Bird & Cronin, LLC

• 00610570191390 - B-Cool Chest & AB Binder Wrap: 2023-05-31
• 00610570191406 - B-Cool Chest & AB Binder Wrap: 2023-05-31
• 00610570191413 - B-Cool Chest & AB Binder Wrap: 2023-05-31
• 50610570191418 - B-Cool Chest & AB Binder Wrap: 2023-05-31
• 00610570191451 - B-Cool Super Sling Plus Universal (Complete Set): 2023-02-28
• 00610570191581 - Short Anklizer Low Profile Walker XS: 2023-02-28
• 00610570191598 - Short Anklizer Low Profile Walker Small: 2023-02-28
• 00610570191604 - Short Anklizer Low Profile Walker Medium: 2023-02-28