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Argyle

FDA UDI

Class II (US FDA UDI)

by Mozarc Medical US LLC

Identity

Trade Name
Argyle FDA UDI
Generic Name
Peritoneal dialysis catheter adaptor, single-use FDA UDI
Device Name
Peritoneal Dialysis Accessory,Titanium Adapter FDA UDI
Model / Reference
8888422378 FDA UDI
Description
Peritoneal Dialysis Accessory,Titanium Adapter FDA UDI

Identifiers

Primary DI / UDI-DI
10884521084506 FDA UDI
510(k) Number
K862046 FDA UDI
FDA Product Code
FJS FDA UDI
GMDN Term
Peritoneal dialysis catheter adaptor, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5630 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Argyle by Mozarc Medical US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K862046 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mozarc Medical US LLC

Sources (1)

  • FDA UDI b3812977-5f99-4e90-bc93-5e319db7be01 36 fields · synced Jun 8, 2026