CompoSeal Mobilea II

Basic Information

• Brand Name: CompoSeal Mobilea II
• Primary DI: 04086000860444
• Version / Model: 9027011
• Catalog Number: 9027011
• Company Name: Fresenius Kabi AG
• Labeler DUNS: 315654579
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-07
• Public Version: 1
• Public Version Date: 2022-11-15
• Public Version Status: New
• Public Device Record Key: 2878ad3c-efbe-42c0-a4db-d0b64dc3bf68

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GHY	Hematocrit, Tube, Rack, Sealer, Holder	Hematology	864.6400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16463	Basic crimper	A hand-held manual device designed to compress (pinch) a non-patient-contact sealing device (e.g., a clip or crimping ring of metal applied apart from the body) to reduce its size (diameter) and create a tight seal on objects being clamped or held together. This is performed by the application of force on the grip of the crimper's handles by the operator. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04086000860444	GS1

Storage Conditions

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