FDA.reportPublic FDA data

IMPROVACUTER® Gel & Clot Activator Tube

Primary DI
16933395621868
Brand
IMPROVACUTER® Gel & Clot Activator Tube
Company
Guangzhou Improve Medical Instruments Co., Ltd.
Model
16x100mm,8.5ml
Device description
This is the Conventional Closure Configurations of IMPROVACUTER® Gel &Clot Activator Tube with the components of Tube, Closure, Clot Activator as well as Serum separating Gel. And the Closure is only made up of Rubber Stopper without Safety Cap. The material of Rubber Stopper is Halogenated butyl rubber.
Published
2019-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093910000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093910000IMPROVACUTER GEL & CLOT ACTIVATOR TUBEGuangzhou Improve Medical Instruments Co., Ltd.2010-07-12JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
46933395621869PackageGS120In Commercial Distribution
16933395621868PrimaryGS10
06933395621649Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4693339562186946933395621869
1693339562186816933395621868
06933395621649069333956216496933395621649

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, clot activator/gel separatorA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, a clot activator and a gel to separate serum from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood serum chemistry determinations). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530148444
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
26974481831058IMPROSAFE® Blood Collection Set with Pre-Attached Holder 27G×2/5”×12”5961273022025-03-14

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