FDA.reportPublic FDA data

Puritan Bennett

Primary DI
10884521782495
Brand
Puritan Bennett
Company
Covidien LP
Model
180-03
Device description
Cuff Pressure Manager
Published
2021-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521782492PackageGS118In Commercial Distribution
10884521782495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452178249220884521782492
1088452178249510884521782495

GMDN Terms#

Term, Definition table
TermDefinition
Artificial airway tube cuff pressure monitorA mains electricity (AC-powered) device intended to intermittently or continuously measure the internal pressure in the cuff of an endotracheal (ET)/endobronchial/tracheostomy tube when this has been situated into the tracheal passage. Too high a cuff pressure and/or combined long periods of use can be damaging for the pressure site on the tracheal wall. It will provide and display a continuous monitoring of the situation which the anaesthetist can observe. Some types may also include the ability to inflate the cuff and regulate the pressure therein.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure62 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Keep dry
Storage Environment Atmospheric Pressure47 KiloPascal108 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521072602V-LocVLOCN204L2015-09-02
20884521126852Sofsilk1700022016-09-24
10884521091986NellcorSC-A-I2026-05-25
10884521758803Vascufil8886470311V-22020-07-19
10884521816312McGRATH MAC350-005-0002021-10-21
10884521816329McGRATH MAC350-013-0002021-08-30
10884521816336McGRATH MAC350-017-0002021-10-18
10884521816343McGRATH MAC350-072-0002022-06-13
10884521824317McGRATH MAC350-005-0002022-09-25
10884521824324McGRATH MAC350-013-0002021-10-30
10884521824331McGRATH MAC350-017-0002021-08-26
10884521824348McGRATH MAC350-072-0002023-06-19
10884521850118McGRATH MAC350-005-0002025-04-27
10884521850125McGRATH MAC350-013-0002025-04-27
10884521850132McGRATH MAC350-017-0002025-04-27
10884521850149McGRATH MAC350-072-0002025-04-27
15060272980310McGRATH MAC350-005-0002021-08-02
15060272980327McGRATH MAC350-013-0002022-01-17
15060272980334McGRATH MAC350-072-0002021-04-18
15060272980341McGRATH MAC350-017-0002021-03-27

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