FDA.reportPublic FDA data

RUSCH

Primary DI
14026704647764
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN914380
Catalog number
112090075
Device description
ETT with Suction, PVC, 7.5
Published
2019-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTRTube, tracheal (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110269000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110269000WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORALWell Lead Medical Co., Ltd.2011-08-26BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704647761PackageGS110In Commercial Distribution
34026704647768PackageGS110In Commercial Distribution
14026704647764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670464776124026704647761
3402670464776834026704647768
1402670464776414026704647764

GMDN Terms#

Term, Definition table
TermDefinition
Cuff-suction endotracheal tubeA hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged mechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. It consists of a ventilation lumen, a cuff-inflation lumen, and a suction lumen; a distal inflatable cuff used to form a seal against the tracheal wall; separate connectors that attach to a breathing circuit and suction system; and a pilot balloon for cuff-pressure monitoring. It typically has a radiopaque marker to guide its placement and is available in various diameters/lengths for adult and paediatric patients. This is a single-use device.

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810003750501KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
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00810003750532KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750549KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750556KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750563KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750570KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750587KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750594KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750600KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750617KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750624KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750631KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750648KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750655KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750662KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750679KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750686KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750693KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750396KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750402KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750419KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750426KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750433KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750440KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750457KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750464KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750471KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27