FDA.reportPublic FDA data

V-Monovette®Urine 10ml bo.acid

Primary DI
04038917263429
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
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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.

Contacts#

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

Regulatory Flags#

DUNS number
388000270
Device count
50
DM exempt
true
Lot or batch
true
Expiration date on label
true

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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