Integra® Miltex®

Integra® Miltex® Jackson Tracheal Tube, Original Pattern, Size 00, Stainless Steel

Registry build 21.09.26
1manufacturer
30catalogue 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 Integra® 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 2023-05-16 (version 6)

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

Catalogue Numbers

Catalogue numbers for Integra® Miltex®
Catalogue number Size Status
23-1156SS Size 8 In distribution
23-1214SS Size 7 In distribution
23-1158SS Size 9 In distribution
23-1200SS Size 0 In distribution
23-1142SS Size 1 In distribution
23-1199SS Size 00 In distribution
23-1219SS Size 10 In distribution
23-1144SS Size 2 In distribution
23-1249SS Size 8 In distribution
23-1212SS Size 6 In distribution
23-1216SS Size 8 In distribution
23-1210SS Size 5 In distribution
23-1247SS Size 6 In distribution
23-1150SS Size 5 In distribution
23-1250SS Size 9 In distribution
23-1152SS Size 6 In distribution
23-1245SS Size 4 In distribution
23-1204SS Size 2 In distribution
23-1159SS Size 10 In distribution
23-1148SS Size 4 In distribution
23-1154SS Size 7 In distribution
23-1246SS Size 5 In distribution
23-1146SS Size 3 In distribution
23-1139SS Size 00 In distribution
23-1208SS Size 4 In distribution
23-1251SS Size 10 In distribution
23-1248SS Size 7 In distribution
23-1206SS Size 3 In distribution
23-1140SS Size 0 In distribution
23-1218SS Size 9 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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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