FDA.reportPublic FDA data

Needle Holder

Primary DI
06974481839166
Brand
Needle Holder
Company
Guangzhou Improve Medical Instruments Co., Ltd.
Model
Quick Release
Catalog number
584010
Published
2026-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KSTSystem, Blood Collection, Vacuum-Assisted, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSTSystem, Blood Collection, Vacuum-Assisted, ManualHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974481839166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974481839166069744818391666974481839166

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

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
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810008214565ONE-CAREMediVena, LLCKST2026-09-11
00810008212301ONE-CAREMediVena, LLCKST2026-09-04
10885380191077CARDINAL HEALTHCardinal Health 200, LLCKST2026-06-08
00199874715100Life PRP LLCLife PRP, LLCKST2026-05-30
00850087212007Life PRP LLCLife PRP, LLCKST2026-05-30
00850024924109Labcorp Comfort DrawMEDTOX DIAGNOSTICS, INC.KST2026-05-22
H671ABCTD0ABC TinyDrawUTAH MEDICAL PRODUCTS, INC.KST2025-09-18
00850033131116Enhanced HARegenlab USA LLCKST2025-08-29
00810185250509TherapakTherapak LLCKST2025-08-11
00810185250516TherapakTherapak LLCKST2025-08-11
04719875918100Transcend Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-08-07
20193489189664MEDLINEMEDLINE INDUSTRIES, INC.KST2025-07-10
30193489189661MEDLINEMEDLINE INDUSTRIES, INC.KST2025-07-10
10810100050457KBMEDKB Medical (group), Inc.KST2025-05-21
10810100050587KBMEDKB Medical (group), Inc.KST2025-05-21
10850016172676KBMEDKB Medical (group), Inc.KST2025-05-21
00810100050078KBMEDKB Medical (group), Inc.KST2025-05-21
00850016172013KBMEDKB Medical (group), Inc.KST2025-05-21
10810100050075KBMEDKB Medical (group), Inc.KST2025-05-21
00810100050450KBMEDKB Medical (group), Inc.KST2025-05-21
00810100050580KBMEDKB Medical (group), Inc.KST2025-05-21
10850016172010KBMEDKB Medical (group), Inc.KST2025-05-21
20810100050454KBMEDKB Medical (group), Inc.KST2025-05-21
20810100050584KBMEDKB Medical (group), Inc.KST2025-05-21
20850016172673KBMEDKB Medical (group), Inc.KST2025-05-21
04719875918070Aeon Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-05-15
04719875918094Virtue Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-05-15
10888277415461MEDLINEMEDLINE INDUSTRIES, INC.KST2025-05-08
20888277415468MEDLINEMEDLINE INDUSTRIES, INC.KST2025-05-08
06974481839128Needle HolderGuangzhou Improve Medical Instruments Co., Ltd.KST2025-03-14