← Back to catalogue

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 27G x 1/2" (0.4mm x 13mm) FDA UDI
Model / Reference
300255 FDA UDI
Description
BD Hypoint™ Needle 27G x 1/2" (0.4mm x 13mm) FDA UDI

Identifiers

Catalog Number
300255 FDA UDI
Primary DI / UDI-DI
00382903002559 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
Length — 0.5 Inch FDA UDI
Needle Gauge — 27 Gauge 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

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

Manufacturer

Manufacturer
Becton Dickinson Medical (s) Pte Ltd

Sources (1)

  • FDA UDI 941e95e8-3b96-42cf-bb04-ac989bf7a3ce 38 fields · synced Jun 1, 2026