N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00817827025037
• Version / Model: T8010
• Catalog Number: T8010
• Company Name: CHARTER MEDICAL, LTD.
• Labeler DUNS: 029062325
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 22493d56-354e-42c2-bddd-8cc615b9adc9

Device Description

Pooling Harness Set 10 Lead Harness Set

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: Yes
• 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
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	864.9100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44903	Blood transfer set	A collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00817827025532	GS1		36	In Commercial Distribution
Primary	00817827025037	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK960043	0