MUELLER HINTON

Primary DI
M20211031
Brand
MUELLER HINTON
Company
Healthlink
Model
1103
Catalog number
1103
Device description
MUELLER HINTON
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JTZCULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/BrothMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945911000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945911000CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARSBioclinical Systems, Inc.1995-04-04JTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M20211032PackageHIBCC10In Commercial Distribution
M20211031PrimaryHIBCC0
M20211030Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mueller-Hinton agar antimicrobial susceptibility culture medium IVDA non-selective Mueller-Hinton agar culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on non-fastidious microorganisms in a clinical specimen and/or culture isolate.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter100Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-2625HLKCustomerSvc@clorox.com

Regulatory Flags#

DUNS number
079376107
Device count
10
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M202398012BOWIE-DICK TYPE TEST PACK pkg of 20 tests398039802016-09-24
M202398023BOWIE-DICK TYPE TEST PACK pkg of 20 tests398039802016-09-24
M20210951MARTIN LEWIS AGAR109510952016-09-24
M20211001MODIFIED THAYER MARTIN110011002016-09-24
M20211041MUELLER HINTON w 5% SB110411042016-09-24
M20211061MUELLER HINTON110611062016-09-24
M20211071MUELLER HINTON w 5% SB110711072016-09-24
M20217371JEMBEC MARTIN LEWIS173717372016-09-24
M202173811JEMBEC MOD THAYER MARTIN173817382016-09-24
M2027657ML2MARTIN LEWIS G.C. SYSTEM7-657-ML7-657-ML2016-09-24
M202V8001MARTIN LEWIS G.C. SYSTEMV800V8002016-09-24
M20215021Bullseye Urine150215022016-09-24
M20234711PROSPORE AUTOCLAVE AMPULE 10/BOX347134712016-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838090981T8006 Sensititre™ Cation Adjusted Mueller-Hinton w/ TES w/ OADC REMEL, INC.JTZ2025-01-16
00848838020667Sensititre Demineralized WaterREMEL, INC.JTZ2024-02-22
00848838091322Sensititre Saline- Tween w/ Glass BeadsREMEL, INC.JTZ2024-02-22
00848838091360Sensititre Middlebrook 7H9 Broth w/OADCREMEL, INC.JTZ2024-02-22
00848838011177Sensititre Demineralized WaterREMEL, INC.JTZ2023-12-21
B6453P240EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JTZ2023-06-07
00848838008092REMELREMEL, INC.JTZ2022-12-22
00848838008115REMELREMEL, INC.JTZ2022-12-22
00848838011061REMELREMEL, INC.JTZ2022-12-22
00848838013294REMELREMEL, INC.JTZ2022-12-22
00848838012280REMELREMEL, INC.JTZ2022-12-22
15099590655754MicroScanBeckman Coulter, Inc.JTZ2021-06-29
00860003684603Mueller Hinton Agar IINEOGEN CORPORATIONJTZ2020-10-20
00860003684610Mueller Hinton Agar IINEOGEN CORPORATIONJTZ2020-10-20
00860003684627Mueller Hinton Agar IINEOGEN CORPORATIONJTZ2020-10-20
00860003684634Mueller Hinton Agar IINEOGEN CORPORATIONJTZ2020-10-20
00816576023608N/AHARDY DIAGNOSTICSJTZ2020-05-27
00816576023592N/AHARDY DIAGNOSTICSJTZ2020-05-27
10382902211768BD BBL™ Mueller Hinton Agar with 5% Sheep BloodBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902211775BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902212758BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902218002BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902218019BD BBL™ Mueller Hinton Agar with 5% Sheep BloodBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902219528BD BBL™ Oxacillin Screen AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902219931BD BBL™ Mueller Hinton Agar with 5% Sheep BloodBECTON, DICKINSON AND COMPANYJTZ2016-12-21
10382902219948BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
30382902212752BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
30382902218006BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
30382902219522BD BBL™ Oxacillin Screen AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21
30382902219942BD BBL™ Mueller Hinton II AgarBECTON, DICKINSON AND COMPANYJTZ2016-12-21