Marketlab Inc

Basic Information

• Brand Name: Marketlab Inc
• Primary DI: 00817517020465
• Version / Model: 5497
• Catalog Number: 5497
• Company Name: MARKETLAB INC.
• Labeler DUNS: 848917027
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2018-11-16
• Public Version: 2
• Public Version Date: 2020-01-22
• Public Version Status: Update
• Public Device Record Key: 0c00e59d-2420-4622-93db-2febfed88251

Device Description

Hematype Segment Device-500/pk

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSS	Supplies, Blood-Bank	Hematology	864.9050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60210	Blood donor bag segment sampling IVD	A sampling device intended to be used for extracting a blood specimen from a blood donor bag tubing segment for analysis and/or other investigation (e.g., blood grouping, cross matching). It typically consists of a needle surrounded by plastic housing designed so that the blood-filled tubing segment may be inserted into the housing, pierced by the needle, and a sample manually extracted without exposing the user to either the blood or the needle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817517020465	GS1
Unit of Use	00817517021240	GS1

Customer Contacts

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