FDA.reportPublic FDA data

NA

Primary DI
20884521134710
Brand
NA
Company
Covidien LP
Model
Y-101400-00
Catalog number
Y-101400-00
Device description
CPAP Interface with Nasal Pillows Assembly,Medium, Large
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
10884521134713PackageGS120Not in Commercial Distribution
20884521134710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452113471310884521134713
2088452113471020884521134710

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, reusableA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit

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
10884521833012BeaconN-19-052026-09-05
10884521833029BeaconN-22-052026-09-05
10884521833036BeaconN-25-052026-09-05
10884521833043SharkCoreDSC-22-012026-09-06
10884521833050SharkCoreDSC-25-012026-09-06
10884521833067SharkCoreC-22-052026-09-06
10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05
10884521833159BeaconDSN-22-012026-09-05
10884521833166BeaconDSN-25-012026-09-05
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29
10884521762688SuperLockSDGN4472021-07-05
10884521837102ILLUMISITEILS-1000-CS2024-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344011858HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011865HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011872HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011889HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011896HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011902HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011919HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011926HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011933HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011940HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011957HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011964HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
00848530109677CPAP Mask KitSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-08-15
00848530109684CPAP Mask KitSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-08-15
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00198843003613Infant Flow™Zoll Medical CorporationBZD2026-08-14
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00198843003675Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003682Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003699Infant Flow™Zoll Medical CorporationBZD2026-08-14
06970819423212RXiBreeze PAP SystemResvent Medical Technology Co., Ltd.BZD2026-08-14
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