FDA.reportPublic FDA data

CuffGuard

Primary DI
03665023001020
Brand
CuffGuard
Company
IDMED
Model
CG-KIT_ID
Device description
CuffGuard complete kit (Main Unit, User manual, 1 tube, clamp for tube and bar, power supply, angle edge)
Published
2025-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
03665023001020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665023001020036650230010203665023001020

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260233256
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665023001112CuffGuardCG-TUB12025-12-19
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
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
03665023001112CuffGuardIDMEDBSK2025-12-19
03665023000948CuffGuardIDMEDBSK2025-12-19
03665023000955CuffGuardIDMEDBSK2025-12-19
03665023000962CuffGuardIDMEDBSK2025-12-19
03665023000979CuffGuardIDMEDBSK2025-12-19
03665023000986CuffGuardIDMEDBSK2025-12-19
03665023000993CuffGuardIDMEDBSK2025-12-19
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