masterguard plus HEMODIALYSIS FISTULA NEEDLE SET

FDA UDI

Class II (US FDA UDI)

by NxStage Medical, Inc.

Identity

Trade Name: masterguard plus HEMODIALYSIS FISTULA NEEDLE SET FDA UDI
Generic Name: Haemodialysis needle FDA UDI
Device Name: SINGLE PACK FISTULA NEEDLE 15G X 1 1/4" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2015MGP FDA UDI
Model / Reference: D9-7015MGP FDA UDI
Description: SINGLE PACK FISTULA NEEDLE 15G X 1 1/4" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2015MGP FDA UDI

Identifiers

Primary DI / UDI-DI: 00842289102446 FDA UDI
FDA Product Code: FIE FDA UDI
GMDN Term: Haemodialysis needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5540 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

Dimensions & Sizes

Size: Needle Gauge — 15 Gauge FDA UDI
Length — 1.25 Inch FDA UDI

Category: Haemodialysis needle

masterguard plus HEMODIALYSIS FISTULA NEEDLE SET by NxStage Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Haemodialysis needle.

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JMS SYSLOC MINI AVF NEEDLE SET — JMS SINGAPORE PTE LTD · Class II
Nipro SafeTouch TULIP Safety Fistula Needle — NIPRO MEDICAL CORPORATION · Class II
JMS HARMONY A.V.FISTULA NEEDLE SET — JMS SINGAPORE PTE LTD · Class II
Nipro SafeTouch TULIP Safety Fistula Needle — NIPRO MEDICAL CORPORATION · Class II
NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE — NIPRO MEDICAL CORPORATION · 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: NxStage Medical, Inc.

Sources (1)

FDA UDI 25f8c10d-0d92-486d-be5d-af1e06dd3c73 36 fields · synced Jun 9, 2026