FDA.report

NA

Primary DI
30848838091699
Brand
NA
Company
REMEL, INC.
Model
7111-42M
Device description
VERSATREK MYCO BOTTLES, W/MODIFIED CAP
Published
2021-12-27
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

Related Records

Contact Domains

Product Codes

CodeName
MDBSystem, Blood Culturing

Product Code Classifications

CodeDeviceSpecialtyClass
MDBSystem, Blood CulturingMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848838091698PrimaryGS10
30848838091699Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838091698008488380916988488380916980848838091698
3084883809169930848838091699

GMDN Terms

TermDefinition
Enriched broth culture medium IVDA broth culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms, from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow in a general-purpose broth medium.

Sterilization Methods

Method

Contacts

PhoneEmail
8002556730csemail@thermofisher.com

Regulatory Flags

DUNS number
065769564
Device count
50
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

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