SAFE-T-FILL®

Basic Information

• Brand Name: SAFE-T-FILL®
• Primary DI: 10643351000090
• Version / Model: 07 7220
• Catalog Number: 07 7220
• Company Name: Ram Scientific, Inc
• Labeler DUNS: 602759672
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 5
• Public Version Date: 2022-12-22
• Public Version Status: Update
• Public Device Record Key: 49ea7312-037e-4b41-a0d9-18502cec3ba9

Device Description

SAFE-T-FILL® Micro Capillary Blood Collection, 200 µL; Prepared with Lithium Heparin and Plasma Separator Gel; Green

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
JKA	Tubes, vials, systems, serum separators, blood collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58145	Non-evacuated blood collection tube IVD, anticoagulant/separator	A non-evacuated glass or plastic tube, sealed with a stopper, containing an anticoagulant [e.g., lithium heparin, ethylenediaminetetraacetic acid (EDTA)] and a separator (e.g., gel) to separate blood plasma from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., plasma chemistry determinations). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50643351000098	GS1	CARTON	80	In Commercial Distribution
Primary	10643351000090	GS1
Package	30643351000094	GS1	CASE	10	In Commercial Distribution
Unit of Use	00643351000093	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K983517	000

Device Sizes

Type	Value	Unit	Text
Total Volume	200	Microliter

Storage Conditions

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