ButtonHole with SteriPick NEEDLE SET

FDA UDI

Class II (US FDA UDI)

by NxStage Medical, Inc.

Identity

Trade Name: ButtonHole with SteriPick NEEDLE SET FDA UDI
Generic Name: Haemodialysis needle FDA UDI
Device Name: SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 16G X 3/5" W/ STERIPICK INCLUDED WITH TWINPACK BH-2036PE FDA UDI
Model / Reference: BH-7036PE FDA UDI
Description: SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 16G X 3/5" W/ STERIPICK INCLUDED WITH TWINPACK BH-2036PE FDA UDI

Identifiers

Primary DI / UDI-DI: 00842289102347 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 — 16 Gauge FDA UDI
Length — .6 Inch FDA UDI

Category: Haemodialysis needle

ButtonHole with SteriPick NEEDLE SET by NxStage Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis needle.

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
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: NxStage Medical, Inc.

Sources (1)

FDA UDI 798038b6-c8d8-480c-bd43-24c96da0d309 36 fields · synced Jun 9, 2026