Port Access Needle

FDA UDI

Class II (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name: Port Access Needle FDA UDI
Generic Name: Vascular port administration set FDA UDI
Device Name: MiniLoc 19G x 1.5 inch FDA UDI
Model / Reference: 0631915 FDA UDI
Description: MiniLoc 19G x 1.5 inch FDA UDI

Identifiers

Catalog Number: 0631915 FDA UDI
Primary DI / UDI-DI: 00801741047510 FDA UDI
FDA Product Code: FPA FDA UDI
GMDN Term: Vascular port administration set 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 19 Gauge FDA UDI
Length — 1.5 Inch FDA UDI

Category: Vascular port administration set

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

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Infusion Safety Products, Inc. — Infusion Safety Products, Inc. · Class II
VYGON — Vygon Corp. · Class II
All-Med, Inc. — ALL-MED INC · Class II
PORT ACCESS INFUSION SET — SB-KAWASUMI LABORATORIES, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bard Access Systems, Inc.

Sources (1)

FDA UDI 732300a9-65c7-47a2-8698-ccce32146a67 36 fields · synced Jun 9, 2026