Value Systems 8621658

GUDID 60889978621651

GENERATOR GRP C 50KW 3P 380-480 VAC

CARESTREAM HEALTH, INC.

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 60889978621651
• NIH Device Record Key: 2ebee66f-e801-47a9-bbb5-69da7fa7cc58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Value Systems
• Version Model Number: Value Systems
• Catalog Number: 8621658
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• 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	60889978621651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201373

FDA Product Code

• KPR: System, x-ray, stationary

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: 2020-10-05
• Device Publish Date: 2020-09-26

On-Brand Devices [Value Systems]

• 60889978621668: GENERATOR GRP D 50KW 3P 208-240 VAC
• 60889978621651: GENERATOR GRP C 50KW 3P 380-480 VAC
• 60889976701539: GENERATOR GRP C 65KW 3P 380-480 VAC
• 60889976701522: GENERATOR GRP C 80KW 3P 380-480 VAC