Comfort Band

GUDID 00811331010176

Comfort Band, Sterile, 14” – Blue

Tz Medical, Inc.

Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use Vascular puncture haemostasis arm clamp/band, single-use

• Primary Device ID: 00811331010176
• NIH Device Record Key: 0e64c321-284e-4321-a510-8877840152b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfort Band
• Version Model Number: CB-8514B
• Company DUNS: 793149709
• Company Name: Tz Medical, Inc.
• Device Count: 10
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811331010176 [Unit of Use]
GS1	10811331010173 [Primary]

FDA Product Code

• MHW: Dressing, Compression

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: 2023-10-30
• Device Publish Date: 2023-10-20

On-Brand Devices [Comfort Band]

• 00811331010183: Comfort Band, Sterile, 17” – Purple
• 00811331010176: Comfort Band, Sterile, 14” – Blue