FDA.reportPublic FDA data

NA

Primary DI
06950456307946
Brand
NA
Company
Hangzhou Tappa Medical Technology Co., Ltd.
Model
EBT0209
Catalog number
EBT0209
Published
2026-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
K251950000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251950000Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)Hangzhou Tappa Medical Technology Co., Ltd.2026-03-20CBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16950456307943PackageGS11In Commercial Distribution
26950456307940PackageGS110In Commercial Distribution
06950456307946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695045630794316950456307943
2695045630794026950456307940
06950456307946069504563079466950456307946

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
+8657188085616sales@tappamed.com

Regulatory Flags#

DUNS number
530863352
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06950456307885NAEBT0109EBT01092026-06-26
06950456307892NAEBT0109SEBT0109S2026-06-26
06950456307908NAEBT0107EBT01072026-06-26
06950456307915NAEBT0107SEBT0107S2026-06-26
06950456307922NAEBT0105EBT01052026-06-26
06950456307939NAEBT0105SEBT0105S2026-06-26
06950456307953NAEBT0209SEBT0209S2026-06-26
06950456307960NAEBT0207EBT02072026-06-26
06950456307977NAEBT0207SEBT0207S2026-06-26
06950456307984NAEBT0205EBT02052026-06-26
06950456307991NAEBT0205SEBT0205S2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950456307885NAHangzhou Tappa Medical Technology Co., Ltd.CBI2026-06-26
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
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
14026704941176SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11