Jms Harmony A.v.fistula Needle Set

FDA UDI

Class II (US FDA UDI)

by Jms Singapore Pte Ltd

Identity

Trade Name: JMS HARMONY A.V.FISTULA NEEDLE SET FDA UDI
Generic Name: Haemodialysis needle FDA UDI
Device Name: HARMONY A.V.FISTULA NEEDLE 14GX1" BE 40CM W/CLAMP FDA UDI
Model / Reference: 827-1402-33 FDA UDI
Description: HARMONY A.V.FISTULA NEEDLE 14GX1" BE 40CM W/CLAMP FDA UDI

Identifiers

Primary DI / UDI-DI: 08888483005468 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 14 Gauge FDA UDI

Category: Haemodialysis needle

Jms Harmony A.v.fistula Needle Set by Jms Singapore Pte Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis needle.

masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS — NxStage Medical, Inc. · Class II
DORA — Bain Medical Equipment (Guangzhou) Co., Ltd. · Class II
Medisystems OneSite dual lumen needle with masterguard — Medisystems Corp. · Class II
Medisystems OneSite dual lumen buttonhole needle with steripick — Medisystems Corp. · Class II
Nipro SafeTouch TULIP Safety Fistula Needle — NIPRO MEDICAL CORPORATION · Class II
ButtonHole with SteriPick NEEDLE SET — NxStage Medical, Inc. · Class II
ButtonHole with SteriPick TWINPACK+ NEEDLE SET — NxStage Medical, Inc. · Class II
Nipro SafeTouch TULIP 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: Jms Singapore Pte Ltd

Sources (1)

FDA UDI e2c9be67-8f5a-40a6-8bdd-968a03c603fc 36 fields · synced May 30, 2026