FDA.reportPublic FDA data

EXIN

Primary DI
04719871894002
Brand
EXIN
Company
FOREMOUNT ENTERPRISE CO., LTD.
Model
152102
Device description
30 M Corrugated Tube (22 mm,cuffed at 0.15 cm,transparent)
Published
2024-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
04719871894002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719871894002047198718940024719871894002

GMDN Terms#

Term, Definition table
TermDefinition
Straight/elbow breathing circuit connector, single-useA device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658718465
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719871896730Aero US1FAXX-00772026-02-12
04719871896747Aero US1FAXX-01012026-02-12
04719871896754Aero US1FAXX-01182026-02-12
04719871896761Aero US1FCXX-00242026-02-12
04719871896778Aero US1FCXX-00262026-02-12
04719871896785Aero US1FDXX-00312026-02-12
04719871896792Aero US1FM4A-00252026-02-12
04719871896808Aero US1FM4A-00352026-02-12
04719871897874KEMP USA10-5012026-02-12
04719871897881KEMP USA10-501-SE2026-02-12
04719871897898KEMP USA10-5252026-02-12
04719871897904KEMP USA10-525-NL2026-02-12
04719871897911KEMP USA10-5262026-02-12
04719871897928KEMP USA10-5142026-02-12
04719871897935Code One1FAXX-00162026-02-12
04719871897942Code One1FAXX-01092026-02-12
04719871892251JBC400-1046/252024-07-18
04719871890011WNLME6201B-FAK5000GIRED2024-06-28
04719871890028WNLME6201NB2-FAK5000SGI2024-06-28
04719871890042WNLME6201NB12-FAK5000SG2024-06-28

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Primary DI, Brand, Company table
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10197344011377HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
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