FDA.reportPublic FDA data

Urinalysis Preservative Tube

Primary DI
16974481837718
Brand
Urinalysis Preservative Tube
Company
Guangzhou Improve Medical Instruments Co., Ltd.
Model
8ml
Published
2025-03-14
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

Product Codes#

Code, Name table
CodeName
FMHContainer, Specimen, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974481837718PackageGS150In Commercial Distribution
46974481837719PackageGS11000In Commercial Distribution
06974481837711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697448183771816974481837718
4697448183771946974481837719
06974481837711069744818377116974481837711

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

Regulatory Flags#

DUNS number
554555378
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
06974481839166Needle HolderQuick Release5840102026-09-21
06974481831047IMPROSAFE® Blood Collection Set with Pre-Attached Holder 25G×3/4”×12”5961253022025-03-14
06974481831054IMPROSAFE® Blood Collection Set with Pre-Attached Holder 27G×2/5”×12”5961273022025-03-14
06974481831115IMPROSAFE® Multi Sample Needle21G×1”5981212502025-03-14
06974481831139IMPROSAFE® Multi Sample Needle21G×1 1/2”5981213802025-03-14
06974481831153IMPROSAFE® Multi Sample Needle22G×1”5981222502025-03-14
06974481831177IMPROSAFE® Multi Sample Needle22G×1 1/2”5981223802025-03-14
06974481833751MPROSAFE® Multi-sample Needle22G×1 1/2”5984223862025-03-14
06974481833768MPROSAFE® Multi-sample Needle21G×1 1/2”5984213862025-03-14
06974481837711Urinalysis Preservative Tube8ml2025-03-14
06974481839036IMPROVACUTER® Disposable TourniquetFor Adult2025-03-14
06974481839128Needle HolderGeneral2025-03-14
06974481839548IMPROVACUTER® TourniquetFor Adult2025-03-14
06974481839555IMPROVACUTER® TourniquetFor Kid2025-03-14
06974481839616Urinalysis Preservative Tube9ml2025-03-14
06974481839715IMPROVACUTER® Multi Sample Needle21G×1”5921212502025-03-14
06974481839722IMPROVACUTER® Multi Sample Needle21G×1 1/2”5921213802025-03-14
06974481839739IMPROVACUTER® Multi Sample Needle22G×1”5921222502025-03-14
06974481839746IMPROVACUTER® Multi Sample Needle22G×1 1/2”5921223802025-03-14
26974481831041IMPROSAFE® Blood Collection Set with Pre-Attached Holder 25G×3/4”×12”5961253022025-03-14

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Primary DI, Brand, Company table
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