GUDID 04713616093477

Relief Cushion Cover 16 x 20" TDX H&R-1p

CARILEX MEDICAL, INC.

Alternating-pressure chair cushion, reusable

• Primary Device ID: 04713616093477
• NIH Device Record Key: 010d065c-5d2f-4c12-8a02-b4f32d9ab7c6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: S2204-A060
• Company DUNS: 658863238
• Company Name: CARILEX MEDICAL, 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: false
• 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	04713616092715 [Primary]
GS1	04713616093477 [Package]; Contains: 04713616092715; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• IMS: Support, Head And Trunk, Wheelchair
• KIC: Cushion, Flotation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-30
• Device Publish Date: 2017-03-22

Devices Manufactured by CARILEX MEDICAL, INC.

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• 14719873698636 - NA: 2025-12-30 Envelop Cover 48" x 80" VTX Carilex-1p
• 04719873693634 - NA: 2025-12-29 VT Drape and Port Set Kit S Lock
• 04719873693641 - NA: 2025-12-29 VT Drape and Port Set Kit M Lock
• 04719873693658 - NA: 2025-12-29 VT Drape and Port Set Kit L Lock
• 04719873698424 - NA: 2025-09-17 CariChair Carry Bag(single-layer)