Lifeguard

FDA UDI

Class II (US FDA UDI)

by Navilyst Medical, Inc.

Identity

Trade Name: Lifeguard FDA UDI
Generic Name: Vascular port administration set FDA UDI
Device Name: LIFEGUARD Safety Needle FDA UDI
Model / Reference: LG-20-50 FDA UDI
Description: LIFEGUARD Safety Needle FDA UDI

Identifiers

Primary DI / UDI-DI: H787LG20505 FDA UDI
510(k) Number: K013871 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

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 20 Gauge FDA UDI
Length — 0.5 Inch FDA UDI

Category: Vascular port administration set

Lifeguard by Navilyst Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular port administration set.

Port Access Needle — Bard Access Systems, Inc. · Class II
VYGON — Vygon Corp. · Class II
VYGON — Vygon Corp. · Class II
Port Access Needle — Bard Access Systems, Inc. · Class II
PowerLoc — Bard Access Systems, Inc. · Class II
Port Access Kit — Bard Access Systems, Inc. · Class II
PORT ACCESS INFUSION SET — SB-KAWASUMI LABORATORIES, INC. · Class II
Port Access Kit — Bard Access Systems, Inc. · Class II

Cleared under the same submission

K013871 also covers:

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: Navilyst Medical, Inc.

Sources (1)

FDA UDI 6c72e04e-a399-4d69-9ff0-3e1c8e0e7a8f 36 fields · synced Jun 6, 2026