CAPILLARY TUBE, CARE-FILL, BUNDLE OF 50

Basic Information

• Brand Name: CAPILLARY TUBE, CARE-FILL, BUNDLE OF 50
• Primary DI: 00809708041137
• Version / Model: AT-0006-00-00
• Catalog Number: AT-0006-00-00
• Company Name: Epocal Inc
• Labeler DUNS: 201179681
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-17
• Public Version: 7
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: 4559174d-cc64-42f9-bfea-65347075f2d2

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
58155	Capillary blood transfer tube IVD, heparin	A glass or plastic capillary blood transfer tube coated internally with the anticoagulant heparin, and intended to be attached to a non-evacuated blood collection tube to assist with the transfer of blood drops from the blood collection site into the collection tube using a capillary action. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00809708041137	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092849	000