RP X-OMAT LO Fixer and Replenisher 8239527

GUDID 60889978239528

RP X-OMAT LO FIXER AND REPL PART B 250GL

CARESTREAM HEALTH, INC.

X-ray film processing chemical, automatic

• Primary Device ID: 60889978239528
• NIH Device Record Key: 5b3dd45c-5aa2-4557-901c-ef75a7283e09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RP X-OMAT LO Fixer and Replenisher
• Version Model Number: RP X-OMAT LO Fixer and Replenisher
• Catalog Number: 8239527
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, 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: 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	60889978239528 [Primary]

FDA Product Code

• IWZ: Film, radiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

On-Brand Devices [RP X-OMAT LO Fixer and Replenisher]

• 60889978868803: RP X-OMAT FIXER AND REPLENISHER 10GL
• 60889978632664: RP X-OMAT LO Fixer and Repl Part A 250GL
• 60889978239528: RP X-OMAT LO FIXER AND REPL PART B 250GL
• 60889975224381: RP X-OMAT LO FIXER AND REPL 2 X 20L