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Procedure Products Adapters

FDA UDI

Class II (US FDA UDI)

by Procedure Products, Inc.

Identity

Trade Name
Procedure Products Adapters FDA UDI
Generic Name
General-purpose catheter connector, sterile FDA UDI
Device Name
Adapter, Lock to Male FDA UDI
Model / Reference
8075 FDA UDI
Description
Adapter, Lock to Male FDA UDI

Identifiers

Primary DI / UDI-DI
B16080751 FDA UDI
510(k) Number
K810921 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
General-purpose catheter connector, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 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

No

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: General-purpose catheter connector, sterile

Procedure Products Adapters by Procedure Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose catheter connector, sterile.

Cleared under the same submission

K810921 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Procedure Products, Inc.

Sources (1)

  • FDA UDI 21ced620-af33-485a-b969-7f76b69b7e3e 34 fields · synced May 30, 2026