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Access 15

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
Access 15 FDA UDI
Generic Name
Instrument trolley FDA UDI
Device Name
PUMP CART ACCESS 15 PUMP FDA UDI
Model / Reference
7205932 FDA UDI
Description
PUMP CART ACCESS 15 PUMP FDA UDI

Identifiers

Catalog Number
7205932 FDA UDI
Primary DI / UDI-DI
03596010441546 FDA UDI
510(k) Number
K000153 FDA UDI
FDA Product Code
HRX FDA UDI
GMDN Term
Instrument trolley FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Instrument trolley

Access 15 by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Instrument trolley.

Cleared under the same submission

K000153 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI f6289c02-b64e-44d0-8150-a3d96a6db70f 36 fields · synced Jun 8, 2026