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SafeStep

FDA UDI

Class II (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name
SafeStep FDA UDI
Generic Name
Peripherally-inserted central venous catheter FDA UDI
Device Name
Port Access Kit FDA UDI
Model / Reference
CPA00044A FDA UDI
Description
Port Access Kit FDA UDI

Identifiers

Catalog Number
CPA00044A FDA UDI
Primary DI / UDI-DI
00801741182983 FDA UDI
FDA Product Code
PTI FDA UDI
GMDN Term
Peripherally-inserted central venous catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

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

Dimensions & Sizes

Size
Needle Gauge — 22 Gauge FDA UDI
Length — 0.75 Inch FDA UDI

Category: Peripherally-inserted central venous catheter

SafeStep by Bard Access Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripherally-inserted central venous catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bard Access Systems, Inc.

Sources (1)

  • FDA UDI ed3434de-264d-4334-af92-a33f57f136de 37 fields · synced Jun 9, 2026