Miltex®

Jackson Trach Short SZ 2 (7034612)

Registry build 21.09.26
1manufacturer
3catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code BTO
Manufacturer City Province Registered as Device types
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46

Record

Regulatory record for Miltex®
Listed by Integra LifeSciences Production Corporation, United States
FDA product code BTO
Device type Tube, Tracheostomy (W/Wo Connector)
Device class Class 2
Regulation 21 CFR 868.5800
Establishment Contract manufacturer, Specification developer, Manufacturer
Premarket notification Exempt
Record published 2017-10-09
Record revised 2022-08-03 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Distribution end date 2022-05-01

Catalogue Numbers

Catalogue numbers for Miltex®
Catalogue number Size Status
23-1202SS Size 1 Withdrawn
23-1243SS Size 2 Withdrawn
23-1244SS Size 3 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Tracoe® comfort Tracoe Medical Gmbh 1,296
Portex ICU Medical, Inc 380
Pilling Teleflex Medical LLC 248
Premier Premier Dental Products Co. 111
Tracoe mini Tracoe Medical Gmbh 110
Sklar® Sklar Corporation 70
Laryngotec Andreas Fahl Medizintechnik-Vertrieb GmbH 66
Blom Pulmodyne Inc. 51
Montgomery® Long-Term Cannula Boston Medical Products, Inc. 48
Bivona ICU Medical, Inc 37
Well Lead Tracheostomy Tube Well Lead Medical Co., Ltd. 36
Integra® Jarit® Integra LifeSciences Production Corporation 36

Showing 12 of 77. All products under Tube, Tracheostomy (W/Wo Connector)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer