ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes

Basic Information

• Brand Name: ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes
• Primary DI: 00831829000403
• Version / Model: 270-109VL
• Catalog Number: 270-109VL
• Company Name: SEPARATION TECHNOLOGY, INC.
• Labeler DUNS: 195501127
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-14
• Public Version: 3
• Public Version Date: 2018-08-09
• Public Version Status: Update
• Public Device Record Key: a6e73909-483c-4863-be45-bdb367bab935

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
57891	Capillary blood collection tube IVD, ammonium heparin	A non-sterile glass or plastic collection tube containing the anticoagulant ammonium 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
Primary	00831829000403	GS1

Customer Contacts

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

Storage Conditions

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