LW Scientific, Inc.

Basic Information

• Brand Name: LW Scientific, Inc.
• Primary DI: 00664816002131
• Version / Model: CNT-ZPC7-40HE
• Catalog Number: CNT-ZPC7-40HE
• Company Name: LW SCIENTIFIC, INC.
• Labeler DUNS: 785335381
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-30
• Public Version: 2
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: 6d19f8f9-2597-4f67-b9fd-97be360ebff5

Device Description

Hematocrit tubes, Glass, Plain, 200/vial, 40mm, for ZIP Combo microhematocrit.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• 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
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	00664816002131	GS1