FDA.reportPublic FDA data

Bartels

Primary DI
05391516747325
Brand
Bartels
Company
CLARK LABORATORIES, INC.
Model
B1029-41A
Catalog number
B1029-41A
Device description
Cul-Trol
Published
2017-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSKSupplement, Culture Media

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSKSupplement, Culture MediaMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K834115000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K834115000CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUTBartels Immunodiagnostic Supplies, Inc.1984-03-23JSK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516747325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516747325053915167473255391516747325

GMDN Terms#

Term, Definition table
TermDefinition
Culture medium antimicrobial supplement IVDA culture medium supplement containing one or multiple antimicrobials that is intended to be used to suppress or inhibit the growth of native or resident microorganisms present in a clinical specimen to enhance recovery, isolation, and/or growth of pathogenic organisms.

Device Sizes#

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

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-325-3424Customerservice@trinityusa.com

Regulatory Flags#

DUNS number
623214079
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391516746595Immco Diagnostics517551752019-10-25
05391516743914Trinity Biotech233900023390002016-09-19
05391516742276Trinity Biotech805A805A2017-05-07
05391516743938Trinity Biotech233910023391002016-09-23
05391516746533Trinity Biotech5257002019-12-27
05391516747455Trinity Biotech43842402019-12-31
05391516743822Trinity Biotech233817023381702016-09-22
05391516743860Trinity Biotech233857023385702016-09-22
05391516747172Trinity Biotech233857123385712016-09-22
05391516747202Trinity Biotech234698023469802016-09-19
05391516747387BartelsB1029-90CB1029-90C2017-05-07
05391516747394BartelsB1029-90DB1029-90D2017-05-07
05391516743372Trinity Biotech232510023251002016-09-21
05391516746960Trinity Biotech232510123251012016-09-21
05391516746588Bio-StatYY601262019-12-30
05391516747424Phoenix BiotechTS-96-Bulk2019-12-30
05391516747493Immco230AWI2019-12-30
05391516746519Trinity Biotech8271022019-12-27
05391516746526Trinity Biotech9154012019-12-27
05391516746687Bio-Rad72517725172019-12-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05407010128727ProLipid Complex - 50 ml SAMPLELonza VerviersJSK2025-09-15
05407010128734ProLipid Complex - 1010 mlLonza VerviersJSK2025-09-15
05407010128741Rec. Hum. Insulin ( # 4506) Suppl - 10LLonza VerviersJSK2025-09-15
05407010128758Rec. Hum. Insulin ( # 4506) Suppl - 500LLonza VerviersJSK2025-09-15
05407010128765Mod ProCHO 5 powder Sup 2 - 20 mlLonza VerviersJSK2025-09-15
05407010128772Mod ProCHO 5 powder Sup 2 - 500LLonza VerviersJSK2025-09-15
05407010128284Ferric Citrate solution - 400 mlLonza VerviersJSK2025-08-11
05407010128246Insulin Solution - 50 ml SAMPLELonza VerviersJSK2025-08-08
05407010128253Insulin Solution - 900 mlLonza VerviersJSK2025-08-08
05407010128260Ferric Citrate solution - 50 ml SAMPLELonza VerviersJSK2025-08-08
05407010128277Ferric Citrate solution - 1L bottleLonza VerviersJSK2025-08-08
05407010127126DMEM Vitamines Stock 100x 1LLonza VerviersJSK2025-05-26
05407010127010MCDB 202 Trace Element BulkLonza VerviersJSK2025-05-23
05407010127034CHO4A Trace element stock - 1L bottleLonza VerviersJSK2025-05-23
05407010127041Stock solution CH-0107N (0.7g/L)Lonza VerviersJSK2025-05-23
05407010127058Stock solution SP-0180T (0.095 g/l)Lonza VerviersJSK2025-05-23
05407010127065Stock solution CH-0146T (0.078 g/l)Lonza VerviersJSK2025-05-23
05407010127072Stock solution CH-0242 (0.4711 g/l)Lonza VerviersJSK2025-05-23
05407010127089Stock solution CH-0116N (0.2162 g/l)Lonza VerviersJSK2025-05-23
05407010127096Stock solution CH-0149N (35.67 mg/l)Lonza VerviersJSK2025-05-23
05407010127102Stock solution CH-0149N (35.67 mg/l)Lonza VerviersJSK2025-05-23
05407010127119CHO7 Lipids 2x 500 ml (resa CSL Behring)Lonza VerviersJSK2025-05-23
05407010126976Lipid Mix CM-105 NN It.no.101-5986-500mlLonza VerviersJSK2025-05-20
05407010126983Lipid Mix CM-105 NN It.no.101-5986 - 20LLonza VerviersJSK2025-05-20
05407010126648SF5-16 Powder Medium - Sup 1 for 5LLonza VerviersJSK2025-04-17
05407010126655SF5-16 Powder Medium - Sup 1 for 500LLonza VerviersJSK2025-04-17
05407010126662SF5-16 Powder Medium - Sup 2 - 5LLonza VerviersJSK2025-04-17
05407010126679SF5-16 Powder Medium - Sup 2 - 500LLonza VerviersJSK2025-04-17
05407010126426proVero complement powder - 500LLonza VerviersJSK2025-03-31
05407010126327GSK-IC-01 supplem. powder 200LLonza VerviersJSK2025-03-25