COMPANION

GUDID 00190446822301

LTC Rechargeable Lithium-Ion Battery

DJO, LLC

Secondary battery

• Primary Device ID: 00190446822301
• NIH Device Record Key: 2a95a420-935d-4486-81bf-9a9fb1a1d61a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPANION
• Version Model Number: PRD-001005-000
• Company DUNS: 081840873
• Company Name: DJO, LLC
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190446822301 [Primary]

FDA Product Code

• MOQ: BATTERY, REPLACEMENT, RECHARGEABLE

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: 2024-08-14
• Device Publish Date: 2024-08-06

Devices Manufactured by DJO, LLC

• 00190446662563 - PROCARE: 2025-07-18 ANKLE BRACE, FIGURE-EIGHT XSM
• 00190446662570 - PROCARE: 2025-07-18 ANKLE BRACE, FIGURE-EIGHT SM
• 00190446662587 - PROCARE: 2025-07-18 ANKLE BRACE, FIGURE-EIGHT MED
• 00190446662594 - PROCARE: 2025-07-18 ANKLE BRACE, FIGURE-EIGHT LG
• 00190446662600 - PROCARE: 2025-07-18 ANKLE BRACE, FIGURE-EIGHT XLG
• 00190446683407 - PROCARE: 2025-07-16 NIGHT SPLINT, DORSAL LG/XLG
• 00190446683414 - PROCARE: 2025-07-16 NIGHT SPLINT, DORSAL SM/MED
• 00190446660545 - PROCARE: 2025-07-15 KNEE IMMOBILIZER, XL 22 IN