End-to-End Volume Capillaries 5 μl

Basic Information

• Brand Name: End-to-End Volume Capillaries 5 μl
• Primary DI: 04061609000439
• Version / Model: ETE005-0100
• Company Name: BIOANALYTIC GmbH, biomed. Analysentechnik
• Labeler DUNS: 327536728
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-02-06
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4594d60b-7d3d-49dc-9099-3d965f930ff1

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: 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
57893	Microcapillary blood collection tube IVD, no additive	A non-sterile glass or plastic microcollection tube, typically sealed at one or both ends with a putty-like substance following specimen collection, containing no additive. It is intended to be used for the collection, and preservation and/or transport, of capillary blood for analysis or other investigation (e.g., neonatal bilirubin). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04061609000439	GS1
Unit of Use	04061609000644	GS1