SAFECAP®

Basic Information

• Brand Name: SAFECAP®
• Primary DI: 05060586450038
• Version / Model: R60-2000M
• Catalog Number: R60-2000M
• Company Name: SAFE-TEC CLINICAL PRODUCTS LLC
• Labeler DUNS: 361287816
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2000
• Record Status: Published
• Publish Date: 2021-01-27
• Public Version: 1
• Public Version Date: 2021-02-04
• Public Version Status: New
• Public Device Record Key: 535dc669-5b85-4b27-bbd5-fea1c9b4481c

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
61388	Capillary blood collection tube IVD, lithium heparin	A non-sterile glass or plastic collection tube containing the anticoagulant lithium heparin, 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
Unit of Use	15060586450035	GS1
Primary	05060586450038	GS1

Customer Contacts

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