FDA.reportPublic FDA data

Newport Medical

Primary DI
10884521540620
Brand
Newport Medical
Company
Newport Medical Instruments, Inc.
Model
BCD43801P
Device description
Universal (22mm ID) Ventilation Breathing Circuit Without Water Trap
Published
2018-09-23
Public version status
Update
Distribution status
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
CAICircuit, breathing (w connector, adaptor, y piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521644700PackageGS110In Commercial Distribution
10884521540620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452164470010884521644700
1088452154062010884521540620

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, reusableAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in Cool Dry Place

Contacts#

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

Regulatory Flags#

DUNS number
050334275
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521510838NewportE360T-ES-NA2019-08-17
10884521544338NewportHT70PM-PT-BR2018-01-31
10884521542204NewportHT70PM-PT-BR2015-10-22
10884521510845NewportE360T-US-NA2019-07-15
10884521541207NewportE360T-ES-NA2015-10-22
10884521541306NewportE360T-US-NA2015-10-22
10884521510647NewportE360E-SY-IN2023-05-01
10884521540965NewportE360E-SY-IN2015-10-22
10884521543928NewportHT70M-ES-NA2018-01-31
10884521542471Newport MedicalPBC465A2018-08-19
10884521542396Newport MedicalPBC335J2018-02-01
10884521541313NewportE360T-WW-IN2015-10-22
10884521544307NewportHT70PM-ES-NA2018-01-31
10884521542181NewportHT70PM-ES-NA2015-10-22
10884521542273NewportHT70PM-WW-UK2015-10-22
10884521540989NewportE360E-WW-IN2015-10-22
10884521510586NewportE360T-BR-BR2019-08-17
10884521510807NewportE360T-SY-IN2019-08-17
10884521544291NewportHT70PM-ES-EU2018-01-31
10884521544376NewportHT70PM-SY-NA2018-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612649217604ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217628PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217642ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217666ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217680PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217703PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217727ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
06923980116179N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116186N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116193N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116209N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
0503026717028922MM SMOOTHBORE BILEVEL BREATHING SYSTEM FOR NKV-330 WITH MONIT. LINEIntersurgical IncorporatedCAI2026-08-18
14896138016692inspired™VINCENT MEDICAL MANUFACTURING CO., LIMITEDCAI2026-08-05
04719874956547Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
04719874956554Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
00848530108809Ventilator accessorySunset Healthcare Solutions, Inc.CAI2026-04-27
10889483584705Vital Signs™AIRLIFECAI2025-03-06
10889483591666Vital Signs™AIRLIFECAI2025-02-18
10889483591925Vital Signs™AIRLIFECAI2025-02-18
10889483591987Vital Signs™AIRLIFECAI2025-02-18
10889483592113Vital Signs™AIRLIFECAI2025-02-18
10889483592496Vital Signs™AIRLIFECAI2025-02-18
10889483592656Vital Signs™AIRLIFECAI2025-02-18
10889483593448Vital Signs™AIRLIFECAI2025-02-18
10889483593561Vital Signs™AIRLIFECAI2025-02-18
10889483593660Vital Signs™AIRLIFECAI2025-02-18
10889483593752Vital Signs™AIRLIFECAI2025-02-18
10889483585627Vital Signs™AIRLIFECAI2025-02-17
10889483585801Vital Signs™AIRLIFECAI2025-02-17
10889483584699Vital Signs™AIRLIFECAI2025-02-11