KERMA KR8002

GUDID 10612606001649

Kerma Ice Bag Bilateral Facial, 5x12

Cardinal Health 200, LLC

Ice bag

• Primary Device ID: 10612606001649
• NIH Device Record Key: 2558963c-45c3-4135-a7c5-935cac2c813f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KERMA
• Version Model Number: 8002
• Catalog Number: KR8002
• Company DUNS: 961027315
• Company Name: Cardinal Health 200, 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612606001642 [Primary]
GS1	10612606001649 [Package]; Contains: 00612606001642; Package: BOX [12 Units]; In Commercial Distribution
GS1	20612606001646 [Package]; Package: CASE [2 Units]; In Commercial Distribution

FDA Product Code

• KYR: BAG, ICE

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: 2026-02-06
• Device Publish Date: 2026-01-29

Devices Manufactured by Cardinal Health 200, LLC

• 10612606001649 - KERMA: 2026-02-06Kerma Ice Bag Bilateral Facial, 5x12
• 10612606001649 - KERMA: 2026-02-06 Kerma Ice Bag Bilateral Facial, 5x12
• 50192253068854 - Monoject: 2026-02-06 35 mL Syringe Catheter Tip
• 20192253068860 - Monoject: 2026-02-06 60 mL Syringe Catheter Tip
• 50198956023077 - CARDINAL HEALTH: 2026-02-06 CRANIOTOMY PACK
• 50198956096927 - CARDINAL HEALTH: 2026-02-06 DSC TOTAL SHOULDER PACK
• 50198956123548 - CARDINAL HEALTH: 2026-02-06 KIT,EAR,BIDMC
• 50198956135589 - CARDINAL HEALTH: 2026-02-06 SPINE NV 152451 PK
• 50198956185218 - CARDINAL HEALTH: 2026-02-06 CLOSING PACK