FDA.reportPublic FDA data

N/A

Primary DI
00819398023108
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
R15
Catalog number
R15
Device description
BHI (Brain Heart Infusion) Broth, 2ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Brain Heart Infusion Broth) For the cultivation of microorganisms.
Published
2020-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSCCulture Media, General Nutrient Broth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSCCulture Media, General Nutrient BrothMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398023115PrimaryGS10
00819398023108Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398023115008193980231158193980231150819398023115
00819398023108008193980231088193980231080819398023108

GMDN Terms#

Term, Definition table
TermDefinition
Basic/simple nutrient broth culture medium IVDA non-selective, non-differential nutrient broth culture medium intended to be used to for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-266-2222techservice@hardydiagnostics.com

Regulatory Flags#

DUNS number
039981550
Device count
20
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816576020058NAE31E312016-09-01
00816576024995N/AG123G1232020-05-18
00816576026968N/AG367G3672024-07-08
00816576027965N/AW95W952020-06-08
00819398028653N/AZ206Z2062020-08-06
00816576027958N/AW95W952020-06-08
00816576024858N/AG105G1052020-05-18
00819398024600N/AY100Y1002020-06-08
00819398024808N/AY110Y1102020-06-09
00819398024907N/AY115Y1152020-06-09
00819398024594N/AY100Y1002020-06-08
00819398023610N/AR76BXR76BX2020-06-05
00819398024242HardyFlask™X26X262020-06-08
00819398025102N/AY130Y1302020-06-09
00819398023603N/AR76BXR76BX2020-06-05
00819398024235HardyFlask™X26X262020-06-08
00819398022118N/AL22L222020-06-03
00819398025560N/AY310Y3102020-06-09
00819398028264N/AMV1MV12020-06-04
00816576027194HardyDisk™Z9495Z94952025-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975278042516JIAOYUEJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-04-21
06975278042523JIAOYUEJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-04-21
06975278042479JIAOYUEJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-04-18
06975278040321JIAOYUEJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-03-13
06975278040093personal lubricantJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-02-22
06975278040109personal lubricantJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-02-22
00810144911496Cell ProAnalytiChem USA, Inc.JSC2025-11-26
00810144911502Cell ProAnalytiChem USA, Inc.JSC2025-11-26
00810144911519Cell ProAnalytiChem USA, Inc.JSC2025-11-26
B645T0415EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0481EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0488EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0755EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0756EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0757EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0764EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0765EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T04151EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T04811EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T04881EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T07551EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T07561EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T07571EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T07641EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T07651EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0040EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0041EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0046EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0047EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0051EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18