SCOOP

Basic Information

• Brand Name: SCOOP
• Primary DI: B181C11HF20
• Version / Model: C-11HF-2
• Catalog Number: C-11HF-2
• Company Name: TRANSTRACHEAL SYSTEMS, INC.
• Labeler DUNS: 826282220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-07
• Public Version: 1
• Public Version Date: 2020-10-15
• Public Version Status: New
• Public Device Record Key: 45697232-0a9a-4fa0-89d5-fece278200b0

Device Description

Transtracheal Catheters and Cleaning Rods (Two Pack) 11cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36231	Oxygen administration transtracheal catheter	A flexible tube intended to be introduced across the tracheal wall to provide supplementary oxygen (O2) to the respiratory tract of a person who is unable to breathe through the nose or mouth because of obstruction. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B181C11HF20	HIBCC

Customer Contacts

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