FDA.reportPublic FDA data

RUSCH

Primary DI
14026704589958
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN046435
Catalog number
MG-02770-002
Device description
EZ Blocker Kit
Published
2015-10-16
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
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
24026704589955PackageGS11In Commercial Distribution
44026704589959PackageGS15In Commercial Distribution
14026704589958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670458995524026704589955
4402670458995944026704589959
1402670458995814026704589958

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 Gauge7French
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Contacts#

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

Regulatory Flags#

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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06970831723369InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
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06970831723550InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
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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