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Phoenix

EUDAMEDFDA UDI

Class A (EU MDR)

Ref 246009Ref 448804Ref 448785Ref 448436Ref 449044Ref 449536Ref 448798Ref 449516Ref 449027Ref 449045Ref 449515Ref 246006Ref 448614Ref 449539Ref 448851Ref 449057Ref 448874Ref 449472Ref 449055Ref 449538Ref 449046Ref 449527Ref 449537Ref 449533Ref 449528Ref 449524Ref 449526Ref 448420Ref 449530Ref 449569Ref 448748Ref 448439Ref 448008

by Becton, Dickinson and Company

Identity

Trade Name
Phoenix EUDAMED
BD Phoenix™ PID FDA UDI
BD Phoenix™ AST-S Indicator Solution FDA UDI
BD Phoenix™ AP AST Indicator Solution FDA UDI
Generic Name
Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent FDA UDI
Device Name
BD Phoenix™ AST-S Indicator Solution EUDAMEDFDA UDI
BD Phoenix™ PID EUDAMEDFDA UDI
BD Phoenix™ AP AST Indicator Solution EUDAMEDFDA UDI
BD Phoenix™ UNMIC-409 EUDAMED
BD Phoenix™ SMIC/ID-11 EUDAMED
BD Phoenix™ PMIC/ID-86 EUDAMED
BD Phoenix™ NMIC/ID-435 EUDAMED
BD Phoenix™ NMIC/ID-492 EUDAMED
BD Phoenix™ PMIC-88 EUDAMED
BD Phoenix™ NMIC/ID-480 EUDAMED
BD Phoenix™ NMIC/ID-504 EUDAMED
BD Phoenix™ NMIC/ID-433 EUDAMED
BD Phoenix™ NMIC-479 EUDAMED
BD Phoenix™ PMIC/ID-95 EUDAMED
BD Phoenix™ NMIC-493 EUDAMED
BD Phoenix™ SMIC/ID-2 EUDAMED
BD Phoenix™ PMIC/ID-600 EUDAMED
BD Phoenix™ NMIC-402 EUDAMED
BD Phoenix™ NMIC-451 EUDAMED
BD Phoenix™ PMIC-600 EUDAMED
BD Phoenix™ NMIC/ID-493 EUDAMED
BD Phoenix™ NMIC-433 EUDAMED
BD Phoenix™ NMIC-486 EUDAMED
BD Phoenix™ NMIC-492 EUDAMED
BD Phoenix™ NMIC-490 EUDAMED
BD Phoenix™ NMIC-487 EUDAMED
BD Phoenix™ NMIC/ID-483 EUDAMED
BD Phoenix™ NMIC/ID-485 EUDAMED
BD Phoenix™ PMIC-84 EUDAMED
BD Phoenix™ NMIC-489 EUDAMED
BD Phoenix™ PMIC/ID-601 EUDAMED
BD Phoenix™ NMIC/ID-406 EUDAMED
BD Phoenix™ PMIC-90 EUDAMED
Model / Reference
246009 EUDAMEDFDA UDI
448008 EUDAMEDFDA UDI
246006 EUDAMEDFDA UDI
448804 EUDAMED
448785 EUDAMED
448436 EUDAMED
449044 EUDAMED
449536 EUDAMED
448798 EUDAMED
449516 EUDAMED
449027 EUDAMED
449045 EUDAMED
449515 EUDAMED
448614 EUDAMED
449539 EUDAMED
448851 EUDAMED
449057 EUDAMED
448874 EUDAMED
449472 EUDAMED
449055 EUDAMED
449538 EUDAMED
449046 EUDAMED
449527 EUDAMED
449537 EUDAMED
449533 EUDAMED
449528 EUDAMED
449524 EUDAMED
449526 EUDAMED
448420 EUDAMED
449530 EUDAMED
449569 EUDAMED
448748 EUDAMED
448439 EUDAMED
Description
BD Phoenix™ PID FDA UDI
BD Phoenix™ AST-S Indicator Solution FDA UDI
BD Phoenix™ AP AST Indicator Solution FDA UDI

Identifiers

Catalog Number
448008 FDA UDI
246009 FDA UDI
246006 FDA UDI
Primary DI / UDI-DI
30382902460092 EUDAMEDFDA UDI
00382904480080 EUDAMEDFDA UDI
30382902460061 EUDAMEDFDA UDI
30382904488049 EUDAMED
00382904487850 EUDAMED
30382904484362 EUDAMED
30382904490448 EUDAMED
30382904495368 EUDAMED
30382904487981 EUDAMED
30382904495160 EUDAMED
00382904490270 EUDAMED
00382904490454 EUDAMED
30382904495153 EUDAMED
00382904486143 EUDAMED
30382904495399 EUDAMED
00382904488512 EUDAMED
30382904490578 EUDAMED
30382904488742 EUDAMED
30382904494729 EUDAMED
30382904490554 EUDAMED
30382904495382 EUDAMED
00382904490461 EUDAMED
00382904495275 EUDAMED
30382904495375 EUDAMED
30382904495337 EUDAMED
30382904495283 EUDAMED
00382904495244 EUDAMED
00382904495268 EUDAMED
00382904484200 EUDAMED
30382904495306 EUDAMED
30382904495696 EUDAMED
00382904487485 EUDAMED
30382904484393 EUDAMED
Basic UDI-DI
038290LXIZYEAHPC EUDAMED
038290IUNUUHJKLW EUDAMED
038290XHOLMCZQKK EUDAMED
038290QWKRAGLOLD EUDAMED
038290NUCZCOAXJ9 EUDAMED
038290LEUBYFIPBA EUDAMED
038290VGJIVRNHHE EUDAMED
038290GAJNVYQL8N EUDAMED
038290JWYZOZMQWW EUDAMED
038290GBJXTIWIA3 EUDAMED
038290GWYVFQJVQE EUDAMED
038290GXYDXFDSL8 EUDAMED
038290AZIKCIZIAX EUDAMED
038290LTNILCUQGP EUDAMED
038290PRUMJWJTQ3 EUDAMED
038290HXSHZZMWQE EUDAMED
038290SYOEMEZZQ4 EUDAMED
038290SQRKDGOCJZ EUDAMED
038290ZZIEDNMOPV EUDAMED
038290LFHGHWBK68 EUDAMED
038290QOQTYPVFSA EUDAMED
038290GNCHDPAP43 EUDAMED
038290KQNHTWXAJB EUDAMED
038290LTTPBOCOKE EUDAMED
038290KTJOTINGHX EUDAMED
038290GIECSJUF44 EUDAMED
038290GIXSFMBNDN EUDAMED
038290EVUBGBPOC7 EUDAMED
038290LRBWODZUH4 EUDAMED
038290QLZXFQVERN EUDAMED
038290JXLYWHQGQH EUDAMED
038290SOFWPSWRPD EUDAMED
038290OVLWZRRMUE EUDAMED
Unit of Use DI
00382902460091 EUDAMED
00382904488048 EUDAMED
00382904484361 EUDAMED
00382904490447 EUDAMED
00382904495367 EUDAMED
00382904487980 EUDAMED
00382904495169 EUDAMED
00382904495152 EUDAMED
00382902460060 EUDAMED
00382904495398 EUDAMED
00382904490577 EUDAMED
00382904488741 EUDAMED
00382904494728 EUDAMED
00382904490553 EUDAMED
00382904495381 EUDAMED
00382904495374 EUDAMED
00382904495336 EUDAMED
00382904495282 EUDAMED
00382904495305 EUDAMED
00382904495695 EUDAMED
00382904484392 EUDAMED
510(k) Number
K050745 FDA UDI
K020321 FDA UDI
FDA Product Code
LQL FDA UDI
LON FDA UDI
EMDN Code
W0104080113 OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...) EUDAMED
W0104080107 GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED EUDAMED
W0104080110 COMBINED SUSCEPTIBILITY AND IDENTIFICATION SYSTEMS GRAM POSITIVES - AUTOMATED EUDAMED
W0104080109 COMBINED SUSCEPTIBILITY AND IDENTIFICATION SYSTEMS GRAM NEGATIVES - AUTOMATED EUDAMED
W0104080108 GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED EUDAMED
W0104080103 GRAM POSITIVE IDENTIFICATION - AUTOMATED EUDAMED
GMDN Term
Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent FDA UDI

Classification

Device Class
Class A EUDAMED
Class B EUDAMED
Class I FDA UDI
Class II FDA UDI
Regulation Number
866.2660 FDA UDI
866.1645 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMEDEUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

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

Yes

FDA UDIFDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 6 Milliliter FDA UDI
Total Volume — 15 Milliliter FDA UDI

Phoenix by Becton, Dickinson and Company — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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

Manufacturer

EUDAMED SRN
US-MF-000018910
Authorised Representative
Becton Dickinson Ireland Limited IE-AR-000007610

Sources (36)

  • EUDAMED cb02d830-97e0-4a59-a83c-bd2d351551d7 61 fields · synced Oct 6, 2026
  • FDA UDI b5c1364c-b7c9-40de-8eb3-2cdd9d5964e4 36 fields · synced May 25, 2026
  • FDA UDI 763a685a-fb99-49f8-a844-daa2a1aaf1c1 38 fields · synced May 30, 2026
  • FDA UDI 01434935-d3e7-412b-8986-8902cd1e7e31 38 fields · synced May 30, 2026
  • EUDAMED 9dd5ff55-9b18-4076-a16a-23262991492c 61 fields · synced Jul 9, 2026
  • EUDAMED da225499-20e2-4ae2-87a3-12a9701f5e12 61 fields · synced Jul 9, 2026
  • EUDAMED 21eadeeb-d766-43f8-a6b3-a8d3a633883f 61 fields · synced Jul 9, 2026
  • EUDAMED 6fd4b769-98e6-47d6-821c-4bc6eeeb6468 61 fields · synced Jul 9, 2026
  • EUDAMED 98a5d910-ab01-4b89-aec4-88ce8e1db89b 61 fields · synced Jul 10, 2026
  • EUDAMED 179054c3-161b-4000-8beb-e574e418634f 61 fields · synced Jul 10, 2026
  • EUDAMED caeb93f2-3cae-48be-ab51-3e87bd21d86d 61 fields · synced Jul 11, 2026
  • EUDAMED d434ab8c-eef4-4282-a007-76ffa72d60c8 61 fields · synced Jul 11, 2026
  • EUDAMED 5be9b127-99d5-4db6-aa25-0bf78df1a72f 61 fields · synced Jul 12, 2026
  • EUDAMED 656f672f-4e67-498a-a98b-4771d200d46c 61 fields · synced Jul 12, 2026
  • EUDAMED 2e7eebb3-70e0-401c-ae95-6150fe5b43cb 61 fields · synced Jul 13, 2026
  • EUDAMED b7247909-c345-4f1f-ab42-96531480332f 61 fields · synced Jul 13, 2026
  • EUDAMED 01cec227-5e4e-40b5-9d9a-e43478c651c8 61 fields · synced Jul 14, 2026
  • EUDAMED cb122d7b-46d0-42e4-8fa6-7105b9a27ae4 61 fields · synced Jul 15, 2026
  • EUDAMED 5f9921d5-be5b-4f8f-ad32-0de4763db10c 61 fields · synced Jul 15, 2026
  • EUDAMED c04ba662-d353-4636-9eb3-c793a5995230 61 fields · synced Jul 17, 2026
  • EUDAMED 47d8988b-b5f0-4439-87c0-d1b7bee3ffcb 61 fields · synced Jul 17, 2026
  • EUDAMED 8ff5476c-a95e-428e-848d-4320f228675c 61 fields · synced Jul 17, 2026
  • EUDAMED 5762c9e0-959b-4083-8f18-400a9dda5108 61 fields · synced Jul 17, 2026
  • EUDAMED 4d21f0b9-5f0f-4e8b-a835-afb02749431e 61 fields · synced Jul 17, 2026
  • EUDAMED 28470cdc-901a-418c-8947-478ee9ea272c 61 fields · synced Jul 19, 2026
  • EUDAMED fc7c50f0-2388-4925-bcfe-531a2f2cac5f 61 fields · synced Jul 20, 2026
  • EUDAMED 8a553e33-5935-413e-928d-943fa7eca675 61 fields · synced Jul 22, 2026
  • EUDAMED 6cbcf912-f042-4b97-82e3-7b4258bb5c7c 61 fields · synced Jul 24, 2026
  • EUDAMED 71391558-172a-4c1b-aaf6-9b3318bf28fb 61 fields · synced Jul 27, 2026
  • EUDAMED 5788ea16-7c73-4414-a2d0-cc422d080ca6 61 fields · synced Jul 28, 2026
  • EUDAMED 95a8dec1-c423-41a4-996f-72ac860ac91c 61 fields · synced Jul 29, 2026
  • EUDAMED c50b62d2-1b80-4622-b0af-82c516bbc2b5 61 fields · synced Jul 30, 2026
  • EUDAMED 64d9a253-6aee-4af2-9a4e-c1b9aa3a7c3d 61 fields · synced Jul 31, 2026
  • EUDAMED b5afe426-5a2b-4f26-b536-7be96e10e47d 61 fields · synced Aug 1, 2026
  • EUDAMED 15b30b51-b69b-4e2a-ae06-e47a9618f8cc 61 fields · synced Aug 2, 2026
  • EUDAMED b4d7bac5-b191-4c85-be8c-a59d5f07dd44 61 fields · synced Aug 2, 2026