TenderTip

Basic Information

• Brand Name: TenderTip
• Primary DI: 05056038303472
• Version / Model: TT04-12-T36
• Catalog Number: TT04-12-T36
• Company Name: GBUK LTD
• Labeler DUNS: 738810980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-02
• Public Version: 1
• Public Version Date: 2023-06-12
• Public Version Status: New
• Public Device Record Key: e70fd7b1-6340-4b2d-9883-e0becdf442d3

Device Description

TenderTip, Suction Catheter, Closed, Single Use Tracheal 12Fr x 36cm

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: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSY	CATHETERS, SUCTION, TRACHEOBRONCHIAL	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10749	Airway suction catheter	A flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05056038303496	GS1	Case	2	In Commercial Distribution
Package	05056038303489	GS1	Box	25	In Commercial Distribution
Primary	05056038303472	GS1