FDA.report

Argyle

Primary DI
50192253042908
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
8888275008
Catalog number
8888275008;
Device description
Argyle Female Luer Adapter Polyethylene
Published
2025-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GCDCONNECTOR, CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
GCDConnector, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253042908PackageGS1100In Commercial Distribution
10192253042900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225304290850192253042908
1019225304290010192253042900

GMDN Terms

TermDefinition
Medical air quick-connect coupling, femaleA female connecting device used to accept a male medical air connector to connect two devices together to provide a continuous passageway for the delivery of medical air. It has safety features such as a specific mechanical mating pattern, colour coding and a dedicated tube diameter connection and allows a user to rapidly connect and disconnect medical air dependent devices. It can be attached, e.g., to medical air regulator or a medical air extension tubing. It can be designed as a diameter-indexed safety system (DISS) connector or a non-interchangeable screw-threaded (NIST) connector. This is not a medical air terminal unit.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

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