← Back to manufacturers

Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

BECTON DICKINSON PEN LIMITED

US

Last updated May 30, 2026

What BECTON DICKINSON PEN LIMITED makes

The company manufactures single-use medical connectors and infusion components, including autoinjector needles like the BD Ultra-Fine and BD Nano series, as well as intravenous administration sets and vial adaptors. Their portfolio also includes infusion system clamps such as the BD PhaSeal and PhaSeal Optima, designed for secure line management during fluid therapy. These products are primarily used in outpatient, hospital, and clinical settings for drug delivery and fluid administration.

The devices fall under FDA-regulated Class I and Class II categories, with most entries listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States, adhering to U.S. regulatory standards for medical device compliance and traceability.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Becton Dickinson Pen Limited manufacture?

Becton Dickinson Pen Limited specializes in single-use medical connectors and infusion components. Their product range includes autoinjector needles like the BD Ultra-Fine and BD Nano series, intravenous administration sets, vial/bottle adaptors, and infusion system clamps such as the BD PhaSeal and PhaSeal Optima. These devices are designed for secure drug delivery and fluid administration in outpatient, hospital, and clinical settings.

Where is Becton Dickinson Pen Limited based, and how does this affect their devices?

Becton Dickinson Pen Limited is based in the United States, which means their devices are subject to U.S. regulatory standards, including compliance with FDA requirements. This includes classification under FDA-regulated categories like Class I and Class II, ensuring traceability and adherence to U.S. medical device regulations.

Which regulatory registries list devices manufactured by Becton Dickinson Pen Limited?

Devices from Becton Dickinson Pen Limited are primarily listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their products, including autoinjectors, intravenous sets, and infusion clamps, ensuring transparency and compliance with U.S. medical device regulations.

How are the devices manufactured by Becton Dickinson Pen Limited classified under U.S. regulations?

The devices produced by Becton Dickinson Pen Limited fall under FDA classifications of Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
bd.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+1(844)823-5433
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
988402590

Catalogue (49)

DeviceModel / ReferenceRegistriesClassStatus
BD Ultra-Fine 320109
FDA UDI
Class IIActive
BD Vacutainer® LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes 368494
FDA UDI
Class IIUnknown
BD Vacutainer® EST™ Blood Collection Tube 362725
FDA UDI
Class IActive
BD Nano 2nd Gen 320550
FDA UDI
Class IIActive
BD Ultra-Fine 320880
FDA UDI
Class IIActive
BD Ultra-Fine 320882
FDA UDI
Class IIActive
BD Preset™ Eclipse™ Arterial Blood Collection Syringe 364390
FDA UDI
Class IIActive
BD Nano Ultra-Fine 320122
FDA UDI
Class IIActive
BD Vacutainer® 9NC 0.109M 2.7 mL 363095
FDA UDI
Class IIActive
BD Seditainer™ 0.105M 1.25ml Buffered Sodium Citrate Blood Collection Tubes 366065
FDA UDI
Class IIActive
BD Vacutainer® SST™ II Advance 367955
FDA UDI
Class IIActive
BD Vacutainer® Plus Citrate Tube 363048
FDA UDI
Class IIActive
BD Seditainer™ Stand 366016
FDA UDI
Class IIUnknown
BD Ultra-Fine 320881
FDA UDI
Class IIActive
BD PhaSeal™ Optima Infusion Clamp M25-O 515085
FDA UDI
Class IActive
BD Vacutainer® 365045
FDA UDI
Class IIUnknown
Pen Needles, 31G x 8MM 320981
FDA UDI
Class IIUnknown
BD Ultra-Fine Pen Needles, 31G x 5MM (Sample) 320367
FDA UDI
Class IIUnknown
BD Vacutainer® SST™ II Advance 366882
FDA UDI
Class IIUnknown
BD Nano 2nd Gen 320551
FDA UDI
Class IIActive
BD Nano Ultra-Fine 320883
FDA UDI
Class IIActive
BD Vacutainer® 365046
FDA UDI
Class IIUnknown
BD Vacutainer® CTAD 367947
FDA UDI
Class IIUnknown
BD PhaSeal 515403
FDA UDI
Class IActive
BD Vacutainer® K2 EDTA (K2E) Plus Blood Collection Tubes 366643
FDA UDI
Class IIActive
BD Nano Ultra-Fine Pen Needles, 32G x 4MM 320540
FDA UDI
Class IIUnknown
BD Vacutainer® 365047
FDA UDI
Class IIActive
BD Vacutainer® 365044
FDA UDI
Class IIUnknown
BD Vacutainer® LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes 368884
FDA UDI
Class IIUnknown
BD Preset™ Eclipse™ Arterial Blood Collection Syringe 364393
FDA UDI
Class IIActive
BD Ultra-Fine 328203
FDA UDI
Class IIActive
BD Vacutainer® SST™ II Advance 367957
FDA UDI
Class IIActive
PhaSeal Optima 515063
FDA UDI
Class IIActive
BD PhaSeal 515301
FDA UDI
Class IIActive
BD Vacutainer® SST™ II Advance 367953
FDA UDI
Class IIActive
BD Vacutainer® LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes 368886
FDA UDI
Class IIUnknown
BD Ultra-Fine 320119
FDA UDI
Class IIActive
BD PhaSeal 515203
FDA UDI
Class IIActive
BD Ultra-Fine Pen Needles, 31G x 8MM (Sample) 320112
FDA UDI
Class IIActive
BD Vacutainer® 365043
FDA UDI
Class IIUnknown
Rite Aid Pen Needles, 31G x 5MM 320982
FDA UDI
Class IIUnknown
BD A-Line™ Arterial Blood Collection Syringe 364378
FDA UDI
Class IIActive
BD Vacutainer® Buffered Sodium Citrate 0.3mL - 0.109M 364305
FDA UDI
Class IIActive
BD Vacutainer® K2E (EDTA) 7.2mg 368861
FDA UDI
Class IIActive
BD Preset™ Eclipse™ Arterial Blood Collection Syringe 364391
FDA UDI
Class IIActive
BD Vacutainer® SST™ II Advance 366444
FDA UDI
Class IIUnknown
BD Preset™ Eclipse™ Arterial Blood Collection Syringe 364389
FDA UDI
Class IIActive
BD Vacutainer® Z (No Additive) Plus Urine Tube 368501
FDA UDI
Class IActive
BD Nano Ultra-Fine Pen Needles, 32G x 4MM (Sample) 320149
FDA UDI
Class IIUnknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.