pts collect™ Capillary Tubes

Basic Information

• Brand Name: pts collect™ Capillary Tubes
• Primary DI: 00381932865012
• Version / Model: 2865
• Catalog Number: 2865
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Labeler DUNS: 835772872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2018-09-18
• Public Version: 4
• Public Version Date: 2022-04-13
• Public Version Status: Update
• Public Device Record Key: 997d1ab4-fb67-45ce-a6cc-ece6f7f37ace

Device Description

The tubes are a combination of a short glass capillary pipette that is physically combined with a plastic pipette that is capable of dispensing a given volume of blood from the capillary tube to a test strip. The glass capillary draws blood from a finger stick site using capillary force. Two small vents in the plastic bulb allow for capillary action. After drawing up of the blood into the glass tube, the two small vents in the plastic tube are then covered with two fingers and the bulb is squeezed to dispense the blood. The PTS Collect capillary tubes are single-use, disposable devices.

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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GIO	TUBE, COLLECTION, CAPILLARY BLOOD	Hematology	864.6150	1

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	00381932865012	GS1
Unit of Use	10381932865019	GS1

Customer Contacts

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