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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
HYPOINT Needle 23 Guage 1 inch TW; sterile single use needle FDA UDI
Model / Reference
300249 FDA UDI
Description
HYPOINT Needle 23 Guage 1 inch TW; sterile single use needle FDA UDI

Identifiers

Catalog Number
300249 FDA UDI
Primary DI / UDI-DI
00382903002498 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 23 Gauge FDA UDI
Length — 1 Inch FDA UDI

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

Cleared under the same submission

K070440 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Becton Dickinson Medical (s) Pte Ltd

Sources (1)

  • FDA UDI ad08b274-1ac8-47ca-bf85-704cfd556acf 38 fields · synced May 30, 2026