BD BACTEC™ Platelet Aerobic/F Culture Vials

Primary DI
30382904420537
Brand
BD BACTEC™ Platelet Aerobic/F Culture Vials
Company
BECTON, DICKINSON AND COMPANY
Model
442053
Catalog number
442053
Device description
Bottle Bactec Platelet Aerobic/F Medium
Published
2023-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZCSystem, detection, bacterial, for platelet transfusion products

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZCSystem, Detection, Bacterial, For Platelet Transfusion ProductsMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK180211000
BK200530000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK180211000
BK200530000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904420537PackageGS150In Commercial Distribution
00382904420536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290442053730382904420537
00382904420536003829044205363829044205360382904420536

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
Total Volume40Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
1
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
true
No natural rubber latex
false
Sterilization required before use
false

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Primary DI, Brand, Model table
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30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00382904420543BD BACTEC™ Platelet Anaerobic/F Culture VialsBECTON, DICKINSON AND COMPANYMZC2023-10-05
30382904420544BD BACTEC™ Platelet Anaerobic/F Culture VialsBECTON, DICKINSON AND COMPANYMZC2023-10-05
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