FDA.report

Urine Monovette® 10ml bor.acid

Primary DI
04038917183147
Brand
Urine Monovette® 10ml bor.acid
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
10.253.020
Catalog number
10.253.020
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JSMCULTURE MEDIA, NON-PROPAGATING TRANSPORT

Product Code Classifications

CodeDeviceSpecialtyClass
JSMCulture Media, Non-Propagating TransportMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038917104548PrimaryGS10
04038917183147Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917104548040389171045484038917104548
04038917183147040389171831474038917183147

GMDN Terms

TermDefinition
Non-evacuated urine specimen container IVD, preservativeA covered receptacle containing one or multiple preservatives [e.g., mercuric oxide, boric acid (H3BO3), benzoic acid, potassium phosphate, and/or sodium phosphate] intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other in vitro diagnostic investigation. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags

DUNS number
388000270
Device count
100
DM exempt
true
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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