SAFE-T-FILL®

Basic Information

• Brand Name: SAFE-T-FILL®
• Primary DI: 10643351000014
• Version / Model: 07 6011
• Catalog Number: 07 6011
• 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: 154827c3-435f-4d94-ae75-39dc28a2bf2f

Device Description

SAFE-T-FILL® Micro Capillary Blood Collection, 125 µL; Prepared with Dipotassium EDTA; Purple

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
58144	Non-evacuated blood collection tube IVD, anticoagulant	A non-evacuated glass or plastic tube, sealed with a stopper, containing an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), lithium heparin, sodium citrate]. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., blood lead, whole blood haematology such as complete blood count (CBC), molecular diagnostics, and immunohaematology testing (ABO grouping, Rh typing, antibody screening, plasma coagulation studies and/or and quantitative drug assay 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	50643351000012	GS1	CARTON	100	In Commercial Distribution
Primary	10643351000014	GS1
Package	30643351000018	GS1	CASE	10	In Commercial Distribution
Unit of Use	00643351000017	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K981973	000

Device Sizes

Type	Value	Unit	Text
Total Volume	125	Microliter

Storage Conditions

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