SAFE-T-FILL®

Basic Information

• Brand Name: SAFE-T-FILL®
• Primary DI: 10643351000281
• Version / Model: 06 0187
• Catalog Number: 06 0187
• Company Name: Ram Scientific, Inc
• Labeler DUNS: 602759672
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2022-10-01
• Public Version: 2
• Public Version Date: 2022-12-22
• Public Version Status: Update
• Public Device Record Key: eb387e82-75ca-4801-b600-ea480c1fe03f

Device Description

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 µL; Prepared with Balanced Heparin

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
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
Package	30643351000285	GS1	PACKAGE	4	In Commercial Distribution
Primary	10643351000281	GS1
Unit of Use	00643351000284	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	230	Microliter

Storage Conditions

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