Tender and Tiny Tourniquets

Basic Information

• Brand Name: Tender and Tiny Tourniquets
• Primary DI: 00815090012426
• Version / Model: 11TA
• Catalog Number: 11TA
• Company Name: SMALL BEGINNINGS INC
• Labeler DUNS: 002657679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2020-08-03
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 6665a5ab-8f94-4fd2-b8e7-8b8510f26293

Device Description

TnT Tourniquets preemie size for infants in the NICU to be used to bring forth the veins during IV or blood sampling.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	878.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58128	Limb tourniquet, manual, single-use	A strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It typically does not include latex and may be available in a variety of designs (e.g., Velcro or a self-locking buckle, synthetic rubber band). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00815090012785	GS1
Primary	00815090012426	GS1
Package	10815090012423	GS1	BOX	12	In Commercial Distribution
Package	20815090012420	GS1	CASE	9	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Preemie