FDA.reportPublic FDA data

V-Monovette®Urine 10ml bo.acid

Primary DI
04038917263436
Brand
V-Monovette®Urine 10ml bo.acid
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
11.2453.001
Catalog number
11.2453.001
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSMCULTURE MEDIA, NON-PROPAGATING TRANSPORT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSMCulture Media, Non-Propagating TransportMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917263429PrimaryGS10
04038917263436Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917263429040389172634294038917263429
04038917263436040389172634364038917263436

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated urine specimen container IVD, preservativeA covered receptacle containing a pre-measured amount of vacuum and 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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags#

DUNS number
388000270
Device count
50
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04066916053802Tube 3.5ml, 92x13 (round), PP62.617.00162.617.0012026-07-21
04038917084093Push cap, neutral65.78265.7822022-11-30
04038917112963Tube 15ml, 120x17mm, PS62.553.04162.553.0412023-11-07
04038917112970Tube 15ml, 120x17mm, PS62.553.04262.553.0422023-11-07
04038917113007Tube 15ml, 120x17mm, PS62.553.54262.553.5422023-11-07
04038917113571Tube 50ml, 115x28mm, PP62.559.01062.559.0102024-10-07
04038917150880Tube 5ml 50x16PS +Cap NAT63.9921.53563.9921.5352023-01-18
04038917151139Tube 10ml 97x16PS+Cap60.9921.83060.9921.8302023-01-18
04038917151528Tube 25ml 90x25PP+Cap60.9922.24360.9922.2432023-01-18
04038917151573Tube 25ml 90x25PP+Cap63.9922.25463.9922.2542023-01-18
04038917155120Tube 10ml, 100x16mm, PP62.9924.27262.9924.2722023-01-18
04038917155137Tube 10ml, 100x16, PP62.9924.27362.9924.2732023-01-18
04038917155144Tube 10ml, 100x16, PP62.9924.27462.9924.2742023-01-18
04038917155182Tube 10ml 100x16PP+Cap62.9924.28362.9924.2832023-01-18
04038917155199Tube 10ml, 100x16mm, PP62.9924.28462.9924.2842023-01-18
04038917155472Set of 4 Tube 12ml 99x16mm60.9924.95260.9924.9522023-01-18
04038917238649Tube 25ml 90x25PP+ Cap63.9922.24863.9922.2482023-01-19
04038917242561Tube 50ml, 114x28mm, PP62.547.27462.547.2742024-10-16
04038917253468Tube 25ml 90x25PP+ Cap60.9922.26060.9922.2602023-01-18
04038917260008Tube 5 ml, 75 x 13 mm , PP55.525.06055.525.0602024-10-24

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