Intravenous-Intraosseous Kit (TMK-IV/IO), Coyote Brown

Basic Information

• Brand Name: Intravenous-Intraosseous Kit (TMK-IV/IO), Coyote Brown
• Primary DI: 00850018892766
• Version / Model: 01323CB
• Catalog Number: 01323CB
• Company Name: Altitude Technologies Inc.
• Labeler DUNS: 621904622
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-27
• Public Version: 2
• Public Version Date: 2023-06-13
• Public Version Status: Update
• Public Device Record Key: ef480860-9fe4-4756-bb53-1e8ea510ac0b

Device Description

The TMK-IV/IO is designed to conveniently house essential intravenous (IV) and intraosseous (IO) infusion supplies and medications for tactical missions.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRS	I.V. Start Kit	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33963	Peripheral intravenous catheterization support kit	A collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850018892766	GS1

Customer Contacts

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