CLINITUBES D957G-70-100X5

Basic Information

• Brand Name: CLINITUBES D957G-70-100X5
• Primary DI: 05700699428783
• Version / Model: 942-878
• Catalog Number: 942-878
• Company Name: Radiometer Medical ApS
• Labeler DUNS: 308667539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 375
• Record Status: Published
• Publish Date: 2022-12-05
• Public Version: 1
• Public Version Date: 2022-12-13
• Public Version Status: New
• Public Device Record Key: 5c6b70ec-8796-4085-8106-b4ad9f20f076

Device Description

D957G-70-100x5 CLINITUBES 5 vials of 75 units. 100 µL. Multipack w. accessories

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
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
Unit of Use	55700699428788	GS1
Primary	05700699428783	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Sensitive to light. Store in a dark place
• Type: Storage Environment Temperature
• Temperature Range: 2 – 32 Degrees Celsius