FDA.reportPublic FDA data

CuffGuard

Primary DI
03665023001112
Brand
CuffGuard
Company
IDMED
Model
CG-TUB1
Device description
Box of 10 connecting tubes
Published
2025-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

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
K243562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243562000CuffGuardIdmed2025-08-12BSK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665023001112PrimaryGS10
03665023001068Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665023001112036650230011123665023001112
03665023001068036650230010683665023001068

GMDN Terms#

Term, Definition table
TermDefinition
Endotracheal tube cuff inflatorA manually-powered device designed to instill air into the cuff of an in situ endotracheal (ET)/endobronchial tube. The inflator typically includes a manually-operated rubber bulb for the delivery of ambient air into the cuff, and a pressure gauge or manometer that displays the pressure within the cuff to help prevent the development of excessive pressure which may cause trauma to the trachea. The purpose of the cuff is to provide an adequate seal for positive pressure ventilation and to prevent aspirated secretions from passing into the lungs. This is a reusable device.

Regulatory Flags#

DUNS number
260233256
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665023000535WiTOFWiTOF-MUWiTOF-MU2025-12-19
03665023000542WiTOFWiTOF-MU2025-12-19
03665023000559WiTOFWiTOF-S2025-12-19
03665023000566WiTOFWiTOF2025-12-19
03665023000573WiTOFWiTOF-FS2025-12-19
03665023000610WiTOFWiTOF-DEMO2025-12-19
03665023000948CuffGuardCG-MU_ID2025-12-19
03665023000955CuffGuardCG-MU_DR2025-12-19
03665023000962CuffGuardPWR5-U_EU2025-12-19
03665023000979CuffGuardPWR5-U_UK2025-12-19
03665023000986CuffGuardPWR5-U_US2025-12-19
03665023000993CuffGuardPWR5-U_TI2025-12-19
03665023001020CuffGuardCG-KIT_ID2025-12-19
03665023001068CuffGuardCG-TUB12025-12-19
03665023002515CuffGuardPWR5-U_TI2025-12-19
03665023002522CuffGuardPWR5-U_EU2025-12-19
03665023002539CuffGuardPWR5-U_UK2025-12-19
03665023002546CuffGuardPWR5-U_US2025-12-19
03665023000030TOF-MUTOF-MUTOF-MU2018-07-13
03665023000122TOF-CHAR_USTOF-CHAR_USTOF-CHAR_US2018-07-13

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
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
10190676008039POSEYPOSEY PRODUCTS, LLCBSK2023-01-25