FDA.reportPublic FDA data

RUSCH

Primary DI
24026704008838
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN041695
Catalog number
116000-000390
Device description
Double lumen bronch. tube, Carlens, l.
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTSTUBE, BRONCHIAL (W/WO CONNECTOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTSTube, Bronchial (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951091000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951091000RUSCH ENDOBRONCHIAL TUBE SETSRusch Intl.1995-06-08BTS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704008834Direct MarkingGS10
44026704008832PackageGS160Not in Commercial Distribution
24026704008838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704008834040267040088344026704008834
4402670400883244026704008832
2402670400883824026704008838

GMDN Terms#

Term, Definition table
TermDefinition
Endobronchial tubeA hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. It is typically made of plastic, rubber, or silicone and may be packaged with a connector that attaches to a breathing circuit and is available in two basic configurations: 1) a double lumen tube with independent cuffs at the distal end for ventilation of the left or right bronchi; or 2) a twin lumen tube with independent cuffs for selective lung ventilation during thoracic surgery or postoperative care when independent lung ventilation is indicated. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge39French
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841495149457QUIKCLOT1831832026-07-17
10841495149464QUIKCLOT1831832026-07-17
10841495149471QUIKCLOT1881882026-07-17
10841495149488QUIKCLOT1881882026-07-17
10841495149495QUIKCLOT3743742026-07-17
10841495149501QUIKCLOT3743742026-07-17
10841495149518QUIKCLOT4584582026-07-17
10841495149549QUIKCLOT4594592026-07-17
10841495149563QUIKCLOT4604602026-07-17
10841495149587QUIKCLOT4614612026-07-17
10841495149600QUIKCLOT467Z467Z2026-07-17
10841495149624QUIKCLOT4874872026-07-17
14026704930644QUIKCLOT1831832026-07-17
14026704930651QUIKCLOT1831832026-07-17
14026704930668QUIKCLOT1881882026-07-17
14026704930675QUIKCLOT1881882026-07-17
14026704930682QUIKCLOT3743742026-07-17
14026704930699QUIKCLOT3743742026-07-17
14026704930705QUIKCLOT4584582026-07-17
14026704930729QUIKCLOT4594592026-07-17

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Primary DI, Brand, Company table
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20884522008775ShileyCovidien LPBTS2018-03-21
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40884522008724ShileyCovidien LPBTS2018-03-21