FDA.reportPublic FDA data

RUSCH

Primary DI
24026704743340
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN926248
Catalog number
MG-02770-002
Device description
EZ-Blocker(TM)
Published
2024-05-20
Public version status
New
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
CBITUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121462000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121462000EZ-BLOCKEREz-Blocker B.V.2012-09-28CBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34026704743347PackageGS15In Commercial Distribution
24026704743340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3402670474334734026704743347
2402670474334024026704743340

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.

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902227239ARROWIPNB00706ASK-04001-NYP22026-08-27
10801902227246ARROWIPNB00152ASK-29903-BSWH2026-08-27
14026704936011QUIKCLOT404040402026-08-27
14026704657169HUDSON RCIIPN91399432302019-05-09
14026704657176HUDSON RCIIPN91399532602019-05-09
04026704303090RUSCHIPN0512673181142016-09-16
04026704387793HUDSON RCIIPN04421532302016-09-16
04026704596430HUDSON RCIIPN04421632602016-09-16
05060112313851LMA AIRWAY MANAGEMENTIPN0478971920302018-09-15
10801902216486ARROWIPN928616EC-050002023-10-26
10801902216516ARROWIPN928618LR-055022023-10-26
10801902216523ARROWIPN928619LR-055032023-10-26
10841156111250GUIDELINERIPN93018852702025-07-14
14026704303448RUSCHIPN0505311807301402016-09-16
14026704303486RUSCHIPN0505351807301802016-09-16
14026704632869DEKNATELIPN0287367-9222019-09-04
14026704670472DEKNATELIPN914541X-4769W2020-05-27
14026704926944RUSCHIPN9297471807052602026-08-25
14026704926951RUSCHIPN9297481807052802026-08-25
14026704926968RUSCHIPN9297491807053002026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06950456307892NAHangzhou Tappa Medical Technology Co., Ltd.CBI2026-06-26
06950456307908NAHangzhou Tappa Medical Technology Co., Ltd.CBI2026-06-26
06950456307915NAHangzhou Tappa Medical Technology Co., Ltd.CBI2026-06-26
06950456307922NAHangzhou Tappa Medical Technology Co., Ltd.CBI2026-06-26
06950456307939NAHangzhou Tappa Medical Technology Co., Ltd.CBI2026-06-26
06950456307946NAHangzhou Tappa Medical Technology Co., Ltd.CBI2026-06-26
06950456307953NAHangzhou Tappa Medical Technology Co., Ltd.CBI2026-06-26
06950456307960NAHangzhou Tappa Medical Technology Co., Ltd.CBI2026-06-26
06950456307977NAHangzhou Tappa Medical Technology Co., Ltd.CBI2026-06-26
06950456307984NAHangzhou Tappa Medical Technology Co., Ltd.CBI2026-06-26
06950456307991NAHangzhou Tappa Medical Technology Co., Ltd.CBI2026-06-26
06970831723659InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-14
06970831723369InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723376InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723383InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723536InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723543InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723550InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723567InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723574InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723581InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723598InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723604InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723611InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723628InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723635InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723642InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
14026704941152SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
14026704941169SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11