FDA.reportPublic FDA data

RUSCH

Primary DI
04026704034543
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN004567
Catalog number
230100-000000
Device description
Connecting Tube
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
BSKCuff, tracheal tube, inflatable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSKCuff, Tracheal Tube, InflatableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951046000RUSCH ENDOTEST CUFF PRESSURE MONITORRusch Intl.1995-04-06BSK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704034547PackageGS110In Commercial Distribution
44026704034541PackageGS162In Commercial Distribution
04026704034543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670403454724026704034547
4402670403454144026704034541
04026704034543040267040345434026704034543

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, reusableAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a reusable 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
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
16979264200000CuffTrekSHANGHAI LONGMANN TECH CO.,LTD.BSK2026-02-12
36979264200004CuffTrekSHANGHAI LONGMANN TECH CO.,LTD.BSK2026-01-23
03665023001112CuffGuardIDMEDBSK2025-12-19
03665023000948CuffGuardIDMEDBSK2025-12-19
03665023000955CuffGuardIDMEDBSK2025-12-19
03665023000962CuffGuardIDMEDBSK2025-12-19
03665023000979CuffGuardIDMEDBSK2025-12-19
03665023000986CuffGuardIDMEDBSK2025-12-19
03665023000993CuffGuardIDMEDBSK2025-12-19
03665023001020CuffGuardIDMEDBSK2025-12-19
03665023001068CuffGuardIDMEDBSK2025-12-19
03665023002515CuffGuardIDMEDBSK2025-12-19
03665023002522CuffGuardIDMEDBSK2025-12-19
03665023002539CuffGuardIDMEDBSK2025-12-19
03665023002546CuffGuardIDMEDBSK2025-12-19
10197344118441MEDLINEMEDLINE INDUSTRIES, INC.BSK2025-06-13
10197344118458MEDLINEMEDLINE INDUSTRIES, INC.BSK2025-06-13
20197344118448MEDLINEMEDLINE INDUSTRIES, INC.BSK2025-06-13
20197344118455MEDLINEMEDLINE INDUSTRIES, INC.BSK2025-06-13
10618125191533PoseyTIDI PRODUCTS, LLCBSK2024-05-03
20618125191530PoseyTIDI PRODUCTS, LLCBSK2024-05-03
00860010850909Pylant MonitorKal-Med, LLCBSK2023-09-01
06920687300870MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
06920687300887MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
06920687303604MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
16920687300877MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
16920687300884MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
16920687303601MedisTianjin Medis Medical Device Co.,Ltd.BSK2023-07-20
10889483002599SunMedSUNMED, LLCBSK2023-07-17
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyBSK2023-04-19