Guardian GS-TB

GUDID 00860008160300

Guardian System Tote Bag

TURNCARE INC

Personal device holder, single-use

• Primary Device ID: 00860008160300
• NIH Device Record Key: 87cbd26e-933d-4b4a-93c7-59864da3eb6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian
• Version Model Number: GS-TB
• Catalog Number: GS-TB
• Company DUNS: 106254663
• Company Name: TURNCARE INC
• 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: false
• 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	00860008160300 [Primary]

FDA Product Code

• FNM: Mattress, Air Flotation, Alternating Pressure

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: 2024-11-15
• Device Publish Date: 2024-11-07

On-Brand Devices [Guardian]

• 00860008160300: Guardian System Tote Bag
• 00860001236491: Guardian System, 2.5 Enhancer Bed-76" integrated tube connector
• 00860001236453: Guardian System, 2.5 Controller
• 00860000205894: Guardian System, 2.5 Enhancer-Seat-70" integrated tube connector
• 00860000205887: Guardian System, 2.5 Enhancer-Procedure Table-70" integrated tube connector
• 00860008160393: Guardian System, Enhancer-Procedure Table-70", integrated tube connector
• 00860008160386: Guardian System, Enhancer-Seat-70", integrated tube connector
• 00860008160379: Guardian System, Enhancer-Bed-76", integrated tube connector
• 00860008160362: Guardian System, Secured-Bed-Surface-76", integrated tube connector (Quad Clip)
• 00860008160355: Guardian System, Secured-Bed-Surface-76", integrated tube connector (Dual Clip)
• 00860008160348: Guardian System Controller with V3 Software