FDA.reportPublic FDA data

Puritan Bennett

Primary DI
10884521141384
Brand
Puritan Bennett
Company
Covidien LP
Model
10001990
Device description
Cushion Adapter Kit,For Nasal Mask CPAP Interface
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002001000BREEZE SLEEPGEAR WITH DREAMSEALPuritan Bennett Corp.2000-09-06BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521141381PackageGS1200Not in Commercial Distribution
10884521141384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452114138120884521141381
1088452114138410884521141384

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521543799SigniaSIGPSHELL2017-08-08
10884521856271Touch SurgeryMDS300012026-10-16
10884521701243INVOSPMAC71DOC2024-04-14
10884521810105INVOSPM71002021-06-14
10884521780170INVOSPMAC71DOC2019-07-31
10884521780071INVOSPM71002019-06-12
10884521839830TrexonCY904P2026-10-10
10884521839861TrexonCY954P2026-10-10
10884521840089TrexonCY811P2026-10-10
10884521840126TrexonCY843P2026-10-10
10884521840140TrexonCY883P2026-10-10
10884521840171TrexonCY953P2026-10-10
10884521840195TrexonGY123P2026-10-10
10884521840249TrexonGY323P2026-10-10
10884521840263TrexonSY823P2026-10-10
10884521840270TrexonSY923P2026-10-10
10884521840379TrexonGY122P2026-10-10
10884521840409TrexonGY322P2026-10-10
10884521840430TrexonSY5628P2026-10-10
10884521840447TrexonSY5638P2026-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06948538347683Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347690Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347706Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347713Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347720Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347737Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347744Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347751Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347768Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347775Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347782Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347799Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347805Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347812Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347829Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347836Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347843Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347850Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347867Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347874Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347881Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347898Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347904Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347911Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347928Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347935Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347942Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347959Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347966Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347973Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15