Marketlab Inc

Basic Information

• Brand Name: Marketlab Inc
• Primary DI: 00817517020045
• Version / Model: 0068
• Catalog Number: 0068
• Company Name: MARKETLAB INC.
• Labeler DUNS: 848917027
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-11-16
• Public Version: 2
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: af04ab68-f75b-43fd-8f8c-06eca1ec41a2

Device Description

SafeCrit Untreated 40mm - 100/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: Yes
• 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
GHY	HEMATOCRIT, TUBE, RACK, SEALER, HOLDER	Hematology	864.6400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35770	Capillary blood collection tube IVD, no additive	A glass or plastic collection tube containing no additive, intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817517020045	GS1
Unit of Use	00817517020915	GS1

Customer Contacts

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