SAFE-T-FILL®

Basic Information

• Brand Name: SAFE-T-FILL®
• Primary DI: 10643351000397
• Version / Model: 06 0507
• Catalog Number: 06 0507
• Company Name: Ram Scientific, Inc
• Labeler DUNS: 602759672
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 4
• Public Version Date: 2022-12-22
• Public Version Status: Update
• Public Device Record Key: 47963879-c06d-4379-a335-c58c2224286c

Device Description

SAFE-T-FILL® MicroHematocrit Capillary Tubes, 50 µL; Plastic, Ammonium Heparinized, Red Marking

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
GHY	HEMATOCRIT, TUBE, RACK, SEALER, HOLDER	Hematology	864.6400	2

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
Package	30643351000391	GS1	PACKAGE	10	In Commercial Distribution
Primary	10643351000397	GS1
Unit of Use	00643351000390	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	50	Microliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight.
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry.