BD Hypoint™

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson Medical (s) Pte Ltd

Identity

Trade Name: BD Hypoint™ FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Device Name: BD Hypoint™ Needle 22G x 1-1/2” TW (0.7mm x 38mm) FDA UDI
Model / Reference: 300263 FDA UDI
Description: BD Hypoint™ Needle 22G x 1-1/2” TW (0.7mm x 38mm) FDA UDI

Identifiers

Catalog Number: 300263 FDA UDI
Primary DI / UDI-DI: 00382903002634 FDA UDI
510(k) Number: K070440 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Hypodermic needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 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

Sterilization Method

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 22 Gauge FDA UDI
Length — 1.5 Inch FDA UDI

Category: Hypodermic needle, single-use

BD Hypoint™ by Becton Dickinson Medical (s) Pte Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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EasyTouch — MHC Medical Products · Class II
STERiJECT TM — TSK LABORATORY, JAPAN · Class II
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Cleared under the same submission

K070440 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: Becton Dickinson Medical (s) Pte Ltd

Sources (1)

FDA UDI d6cbd69c-4590-40a8-8c0c-cb8421404bcf 37 fields · synced Jun 8, 2026