DARCO® AirTraveler™ Walker Liner ATSL0

GUDID 20609271999064

XS Blue low version

DARCO INTERNATIONAL, INC.

Inflatable extremity splint

• Primary Device ID: 20609271999064
• NIH Device Record Key: ecf46c2e-d3d5-41b0-a500-821ff92af8f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DARCO® AirTraveler™ Walker Liner
• Version Model Number: ATSL0
• Catalog Number: ATSL0
• Company DUNS: 184231298
• Company Name: DARCO INTERNATIONAL, 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	00609271999060 [Primary]
GS1	10609271999067 [Package]; Contains: 00609271999060; Package: Box [4 Units]; In Commercial Distribution
GS1	20609271999064 [Package]; Contains: 00609271999060; Package: Case [12 Units]; In Commercial Distribution

FDA Product Code

• FZF: SPLINT, EXTREMITY, INFLATABLE, EXTERNAL

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: 2023-02-16
• Device Publish Date: 2023-02-08

On-Brand Devices [DARCO® AirTraveler™ Walker Liner]

• 10609271999463: XL Blue low version
• 20609271999361: L Blue low version
• 10609271999265: M Blue low version
• 20609271999163: S Blue low version
• 20609271999064: XS Blue low version
• 00609271989467: XL Blue high version
• 00609271989368: L Blue high version
• 00609271989269: M Blue high version
• 00609271989160: S Blue high version
• 00609271989061: XS Blue high version