NuStat Flex XR

GUDID 00850392006254

BEEKEN BIOMEDICAL LLC

Wound dressing kit, non-medicated, sterile

• Primary Device ID: 00850392006254
• NIH Device Record Key: 86a2e66f-16cf-4d7b-aca4-ea7efa1f4260
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuStat Flex XR
• Version Model Number: 3000097320
• Company DUNS: 028807882
• Company Name: BEEKEN BIOMEDICAL LLC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850392006254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160578

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2021-01-18
• Device Publish Date: 2021-01-08

On-Brand Devices [NuStat Flex XR]

• 00850392006537: XR-3000097317
• 00850392006520: XR-3000097333
• 00850392006513: XR-3000097320
• 00850392006506: XR-3000097331
• 00850392006278: 3000097333
• 00850392006261: 3000097331
• 00850392006254: 3000097320
• 00850392006247: 3000097319
• 00850392006230: 3000097318
• 00850392006223: 3000097317