FDA.reportPublic FDA data

AnaeroGRO

Primary DI
00819398026321
Brand
AnaeroGRO
Company
HARDY DIAGNOSTICS
Model
AG25H
Catalog number
AG25H
Device description
Anaerobic Transport Medium, 15x103mm Tube with Hungate Septum Cap and No Swabs, 7ml. Hardy Diagnostics AnaeroGRO™ Anaerobic Transport Medium is recommended for use in maintaining the viability of obligate anaerobic microorganisms, as well as aerobic and facultatively anaerobic bacteria, during transport. Starswab™ Anaerobic Transport Systems are enclosed, self-contained, ready-to-use, sterile surgery packs, available with or without swabs, for maintaining anaerobic transport of clinical specimens.
Published
2020-05-13
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
JSLCulture Media, Anaerobic Transport

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSLCulture Media, Anaerobic TransportMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K944847000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K944847000KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEMStarplex Scientific, Inc.1995-02-16JSL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398026338PrimaryGS10
00819398026321Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398026338008193980263388193980263380819398026338
00819398026321008193980263218193980263210819398026321

GMDN Terms#

Term, Definition table
TermDefinition
Anaerobic transport medium IVDA vessel containing transport medium intended to be used for the preservation and transport of anaerobic 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
false
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
00840165400402Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00840165400426Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00840165400440Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00840165400419Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00840165400433Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00840165400457Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00842558116419ACT I Transport PK/10REMEL, INC.JSL2024-08-06
00842558116426ACT II Transport PK/10REMEL, INC.JSL2024-08-06
00842558116433ACT II Dual Transport PK/10REMEL, INC.JSL2024-08-06
38053326002077 CultureSwab™ MaxV(+)COPAN ITALIA SPAJSL2023-06-14
58053326002071 CultureSwab™ MaxV(+)COPAN ITALIA SPAJSL2023-06-14
38053326001919BD BBL ™ CultureSWAB ™ COPAN ITALIA SPAJSL2023-03-03
38053326009823Transystem™ COPAN ITALIA SPAJSL2023-03-03
58053326001913BD BBL ™ CultureSWAB ™ COPAN ITALIA SPAJSL2023-03-03
58053326009827Transystem™ COPAN ITALIA SPAJSL2023-03-03
28053326000588Transystem™ COPAN ITALIA SPAJSL2022-12-07
28053326000595Transystem™ COPAN ITALIA SPAJSL2022-12-07
28053326000601Transystem™ COPAN ITALIA SPAJSL2022-12-07
28053326000861Transystem™ COPAN ITALIA SPAJSL2022-12-07
28053326001219Transystem™ COPAN ITALIA SPAJSL2022-12-07
28053326001578Transystem™ COPAN ITALIA SPAJSL2022-12-07
28053326004913Transystem™ COPAN ITALIA SPAJSL2022-12-07
38053326001605BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07
38053326001827BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07
38053326001834BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07
38053326001841BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07
38053326001858BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07
38053326001865BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07
38053326001896BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07
38053326001902BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07