DCA® Systems Hemoglobin A1c capillary holders

Basic Information

• Brand Name: DCA® Systems Hemoglobin A1c capillary holders
• Primary DI: 00630414171142
• Version / Model: 10888741
• Catalog Number: 10888741
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-03-01
• Public Version: 5
• Public Version Date: 2021-11-19
• Public Version Status: Update
• Public Device Record Key: 2ef1673d-40cf-4698-9cb1-d6655145c17f

Device Description

A blood collection tube holder; to be used with DCA® Systems HbA1c Reagent Cartridge.

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: 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
LCP	ASSAY, GLYCOSYLATED HEMOGLOBIN	Hematology	864.7470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61419	Capillary blood collection tube IVD, electrolyte-balanced heparin	A non-sterile glass or plastic collection tube containing electrolyte-balanced heparin (anticoagulant), intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin, plasma chemistry determinations). 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	00630414171142	GS1
Unit of Use	00630414211039	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K951361	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius