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MUELLER HINTON w 5% SB

FDA UDI

Class II (US FDA UDI)

by Healthlink

Identity

Trade Name
MUELLER HINTON w 5% SB FDA UDI
Generic Name
Mueller-Hinton agar antimicrobial susceptibility culture medium IVD, sheep blood FDA UDI
Device Name
MUELLER HINTON w 5% SB FDA UDI
Model / Reference
1107 FDA UDI
Description
MUELLER HINTON w 5% SB FDA UDI

Identifiers

Catalog Number
1107 FDA UDI
Primary DI / UDI-DI
M20211071 FDA UDI
510(k) Number
K945911 FDA UDI
FDA Product Code
JTZ FDA UDI
GMDN Term
Mueller-Hinton agar antimicrobial susceptibility culture medium IVD, sheep blood FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.1700 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

No

FDA UDI

Over-the-Counter

Yes

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

Dimensions & Sizes

Size
Outer Diameter — 150 Millimeter FDA UDI

Category: Mueller-Hinton agar antimicrobial susceptibility culture medium IVD, sheep blood

MUELLER HINTON w 5% SB by Healthlink — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mueller-Hinton agar antimicrobial susceptibility culture medium IVD, sheep blood.

Cleared under the same submission

K945911 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Healthlink

Sources (1)

  • FDA UDI b549ed20-e3bf-4f93-9aba-1c003bdae9cd 38 fields · synced May 30, 2026