FDA.reportPublic FDA data

Miltex®

Primary DI
H834231208SS0
Brand
Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
23-1208SS
Catalog number
23-1208SS
Device description
JACKSON TRACH SZ 4 REG (7034314)
Published
2017-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTOTube, tracheostomy (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780038719PrimaryGS10
H834231208SS0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178003871910381780038719

GMDN Terms#

Term, Definition table
TermDefinition
Basic tracheostomy tube, reusableA hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes (however is not custom-made for a specific patient). It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

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10192253052893ArgyleCardinal Health 200, LLCBTO2024-07-15
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10192253052916ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052923ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052930ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052954ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052978ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052985ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052992ArgyleCardinal Health 200, LLCBTO2024-02-16
14026704646699RUSCHTELEFLEX INCORPORATEDBTO2019-07-01
14026704646705RUSCHTELEFLEX INCORPORATEDBTO2019-07-01
M6898250001010Mojo RFR First Responder SetSafeguard US Operating, LLCBTO2018-06-04
M6898260001010Mojo RFR Airway & Respiration SetSafeguard US Operating, LLCBTO2018-06-04
10884521751354ShileyCovidien LPBTO2018-02-06
10884521751361ShileyCovidien LPBTO2018-02-06
10381780038542Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038559Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038566Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038573Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038580Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038597Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038603Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038610Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038627Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09