CompoSeal Mobilea II 9027011

GUDID 04086000860444

The CompoSeal Mobilea II is intended to be used to seal medical PVC tubing hermetically and create break-off point.

Fresenius Kabi AG

Basic crimper

• Primary Device ID: 04086000860444
• NIH Device Record Key: 2878ad3c-efbe-42c0-a4db-d0b64dc3bf68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompoSeal Mobilea II
• Version Model Number: 9027011
• Catalog Number: 9027011
• Company DUNS: 315654579
• Company Name: Fresenius Kabi AG
• 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: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Transp. and storage Cond.: Temperature: -20°C - +70°C Rel. Air Hum: 30-75% Air-Pressure: 500-1060 hPa

Device Identifiers

Device Issuing Agency	Device ID
GS1	04086000860444 [Primary]

FDA Product Code

• GHY: Hematocrit, Tube, Rack, Sealer, Holder

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: 2022-11-15
• Device Publish Date: 2022-11-07

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