CIRCASSIST

GUDID 16975298105014

DVT PROPHYLAXIS SLEEVE CALF LARGE

B & J Manufacturing Ltd.

Single-chamber venous compression system garment, single-use Single-chamber venous compression system garment, single-use Single-chamber venous compression system garment, single-use Single-chamber venous compression system garment, single-use Single-chamber venous compression system garment, single-use Single-chamber venous compression system garment, single-use Single-chamber venous compression system garment, single-use Single-chamber venous compression system garment, single-use Single-chamber venous compression system garment, single-use Single-chamber venous compression system garment, single-use Single-chamber venous compression system garment, single-use Single-chamber venous compression system garment, single-use Single-chamber venous compression system garment, single-use

• Primary Device ID: 16975298105014
• NIH Device Record Key: 17e736c3-1f86-4514-85f2-572d026c3005
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CIRCASSIST
• Version Model Number: CA-INT101L
• Company DUNS: 526120281
• Company Name: B & J Manufacturing Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Circumference: 24 Inch
• Circumference: 24 Inch
• Circumference: 24 Inch
• Circumference: 24 Inch
• Circumference: 24 Inch
• Circumference: 24 Inch
• Circumference: 24 Inch
• Circumference: 24 Inch
• Circumference: 24 Inch
• Circumference: 24 Inch
• Circumference: 24 Inch
• Circumference: 24 Inch
• Circumference: 24 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975298105017 [Primary]
GS1	16975298105014 [Package]; Contains: 06975298105017; Package: Inner Carton [10 Units]; In Commercial Distribution
GS1	26975298105011 [Package]; Package: Outer Carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201532

FDA Product Code

• JOW: Sleeve, Limb, Compressible

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: 2022-05-31
• Device Publish Date: 2022-05-23

On-Brand Devices [CIRCASSIST]

• 06975298105000: DVT PROPHYLAXIS SLEEVE CALF MEDIUM
• 16975298105014: DVT PROPHYLAXIS SLEEVE CALF LARGE