Medisystems OneSite dual lumen needle with masterguard

FDA UDI

Class II (US FDA UDI)

by Medisystems Corp.

Identity

Trade Name: Medisystems OneSite dual lumen needle with masterguard FDA UDI
Generic Name: Haemodialysis needle FDA UDI
Model / Reference: DL-2004MGE FDA UDI

Identifiers

Primary DI / UDI-DI: 00842289100763 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: Length — 1 Inch FDA UDI
Needle Gauge — 14 Gauge FDA UDI

Category: Haemodialysis needle

Medisystems OneSite dual lumen needle with masterguard by Medisystems Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Medisystems Corp.

Sources (1)

FDA UDI 40fb66ad-1f15-494e-b5f1-7c4f98d97af7 35 fields · synced May 30, 2026