NA

Basic Information

• Brand Name: NA
• Primary DI: 07613153088820
• Version / Model: 0225028085S5
• Catalog Number: 0225-028-085S5
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-23
• Public Version: 6
• Public Version Date: 2023-08-24
• Public Version Status: Update
• Public Device Record Key: dc776cb8-b8ae-48ce-a2bd-e142647b33a9
• Distribution End Date: 2019-04-01

Device Description

CBCII with Quick Disconnect and Double Trocar

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAC	APPARATUS, AUTOTRANSFUSION	Anesthesiology	868.5830	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46263	Whole-blood-recovery autotransfusion system, manual	An assembly of manual devices intended to be used to collect, filter, and reinfuse intraoperative and/or postoperative autologous blood shed during and/or after surgery. It is a closed-circuit system that typically includes a manual aspiration (suction) pump, a collection container, reinfusion bag, safety clamps, non-return valves, blood screening filters, and a transfusion set; a drain(s) and/or trocar(s) may also be included in the system. It may facilitate connection to the wall outlet of a vacuum system for aspiration. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37613153088821	GS1	pack	6	Not in Commercial Distribution	2019-04-01
Primary	07613153088820	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	13.0	Inch
Length	21.0	Inch
Height	12.0	Inch

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius