Sanford Children's Hospital Adaptation Pack

Basic Information

• Brand Name: Sanford Children's Hospital Adaptation Pack
• Primary DI: 00607567208421
• Version / Model: BEQ TOP 53400
• Catalog Number: 709000213
• Company Name: DATASCOPE CORP.
• Labeler DUNS: 001660786
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-20
• Public Version: 5
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 73cd9797-3efb-470a-ae69-928d9b24f404
• Distribution End Date: 2016-02-20

Device Description

Soft Shell Venous Reser 800 mL Blood Transfer Bag 1000 mL CDI Sat Cell 1/4 Gas Filter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWE	Tubing, Pump, Cardiopulmonary Bypass	Cardiovascular	870.4390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35441	Cardiopulmonary bypass system blood tubing set	A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00607567208421	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius