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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
Medical device adhesive FDA UDI
Device Name
Peritoneal Dialysis Accessory,Medical Grade Silicone Adhesive, Type A FDA UDI
Model / Reference
8810807001 FDA UDI
Description
Peritoneal Dialysis Accessory,Medical Grade Silicone Adhesive, Type A FDA UDI

Identifiers

Primary DI / UDI-DI
10884521003927 FDA UDI
510(k) Number
K780449 FDA UDI
FDA Product Code
FJS FDA UDI
GMDN Term
Medical device adhesive FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5630 FDA UDI
Commercial Distribution
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

Category: Medical device adhesive

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

Similar devices

Also classified as Medical device adhesive.

Cleared under the same submission

K780449 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 c4735bdc-9d28-4e6b-bb54-33d65d9cf65c 36 fields · synced Jun 8, 2026