TubeChek-B

Basic Information

• Brand Name: TubeChek-B
• Primary DI: 05707480134885
• Version / Model: 000172002
• Catalog Number: 000172002
• Company Name: Ambu A/S
• Labeler DUNS: 305682023
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-10
• Public Version: 4
• Public Version Date: 2022-02-10
• Public Version Status: Update
• Public Device Record Key: fa7fd55a-1320-4e61-a49a-0b246fac8527
• Distribution End Date: 2022-02-10

Device Description

Ambu TubeChek B, Bulb model Minimum order sales is 20 pcs.

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: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTR	Tube, tracheal (w/wo connector)	Anesthesiology	868.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17614	Exhaled-gas oesophageal intubation detector, adult	A device designed to verify proper endotracheal (ET) tube placement by detecting/assessing escaping levels of exhaled carbon dioxide (CO2) during airway management disclosing potential incorrect intubation. It is used during adult intubation and is attached directly between the ET tube and the breathing device. It typically functions through colorimetric CO2 detection using an indicator paper that changes colour. A colour chart (e.g., attached to the device) permits interpretation into approximate CO2 concentration. It is used in healthcare facilities or in the field to evaluate oesophageal intubation, which if performed incorrectly, prevents patient ventilation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05707480005307	GS1		8	Not in Commercial Distribution	2022-02-10
Package	05707480029655	GS1		20	Not in Commercial Distribution	2022-02-10
Primary	05707480134885	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	45	Gram
Outer Diameter	59	Millimeter
Length	83	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: High: 50 Degrees Celsius