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BD Phoenix™ PMIC-108

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
BD Phoenix™ PMIC-108 FDA UDI
Generic Name
Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
Device Name
BD Phoenix™ PMIC-108 FDA UDI
Model / Reference
448418 FDA UDI
Description
BD Phoenix™ PMIC-108 FDA UDI

Identifiers

Catalog Number
448418 FDA UDI
Primary DI / UDI-DI
30382904484188 FDA UDI
510(k) Number
K020322 FDA UDI
K021954 FDA UDI
K022172 FDA UDI
K023273 FDA UDI
K023301 FDA UDI
K024152 FDA UDI
K030677 FDA UDI
K031306 FDA UDI
K031589 FDA UDI
K031679 FDA UDI
K032131 FDA UDI
K033784 FDA UDI
K033907 FDA UDI
K040006 FDA UDI
K040106 FDA UDI
K040716 FDA UDI
K050555 FDA UDI
K051689 FDA UDI
K053241 FDA UDI
K060214 FDA UDI
K060217 FDA UDI
K060218 FDA UDI
K060493 FDA UDI
K070809 FDA UDI
K082538 FDA UDI
K082852 FDA UDI
K131331 FDA UDI
FDA Product Code
LON FDA UDI
GMDN Term
Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.1645 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Category: Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent

BD Phoenix™ PMIC-108 by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent.

Cleared under the same submission

K020322 also covers:

K021954 also covers:

K022172 also covers:

K023273 also covers:

K023301 also covers:

K024152 also covers:

K030677 also covers:

K031306 also covers:

K031679 also covers:

K032131 also covers:

K033784 also covers:

K033907 also covers:

K040006 also covers:

K040106 also covers:

K040716 also covers:

K050555 also covers:

K051689 also covers:

K053241 also covers:

K060214 also covers:

K060217 also covers:

K060218 also covers:

K060493 also covers:

K070809 also covers:

K082538 also covers:

K082852 also covers:

K131331 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Becton Dickinson And Company

Sources (1)

  • FDA UDI 9cf969d1-9f65-412f-ae79-4974d7c06c79 37 fields · synced May 30, 2026