FDA.reportPublic FDA data

Breathing circuit set, dual limb

Primary DI
07630002804318
Brand
Breathing circuit set, dual limb
Company
Hamilton Medical AG
Model
260182
Device description
Dual limb breathing circuit set with Swivel Y-piece, neonatal flow sensor and pressure line for use with all HAMILTON ventilators, 300 cm, neonatal, single-use
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17630002804315PackageGS110In Commercial Distribution
07630002804318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1763000280431517630002804315
07630002804318076300028043187630002804318

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn 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 to a patient artificial airway/respiratory mask (not included). 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; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(775) 858-3200info@hamiltonmedical.com

Regulatory Flags#

DUNS number
481492312
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630002800754HAMILTON-T11610051610052024-08-21
07630002802208HAMILTON-G51590021590022024-08-21
07630002800730HAMILTON-C21600021600022024-08-20
07630002802222HAMILTON-C31600061600062024-08-20
07630002801560HAMILTON-BC80222601612601612016-10-04
07630002806930Breathing circuit set, coaxial2602402022-12-08
07630002800303Breathing circuit set, coaxial2602072022-12-08
07630002800327Breathing circuit set, coaxial2602062022-12-08
07630002800860Flow sensor2816372022-12-08
07630002800877Flow sensor2820492022-12-08
07630002800891Flow sensor2820512022-12-08
07630002800921Breathing circuit set, coaxial2600872022-12-08
07630002800945Breathing circuit set, coaxial2600942022-12-08
07630002801133Expiratory valve set1602452022-12-08
07630002801362Flow sensor1555002022-12-08
07630002801935Breathing circuit set, coaxial2601442022-12-08
07630002801959Breathing circuit set, coaxial2601452022-12-08
07630002801980Expiratory valve set1611752022-12-08
07630002802529Flow sensor9501852022-12-08
07630002802734Expiratory valve set1611862022-12-08

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