FDA.reportPublic FDA data

IMPROVACUTER® Multi Sample Needle

Primary DI
46933395621203
Brand
IMPROVACUTER® Multi Sample Needle
Company
Guangzhou Improve Medical Instruments Co., Ltd.
Model
21G × 1″
Published
2016-12-26
Public version status
Update
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
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153388000IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample NeedleGuangzhou Improve Medical Instruments Co., Ltd.2016-06-07FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
46933395621203PackageGS140In Commercial Distribution
16933395621202PrimaryGS10
06933395621205Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4693339562120346933395621203
1693339562120216933395621202
06933395621205069333956212056933395621205

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient. It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike however it does not include a blood collection tube holder. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530148444
Device count
100
DM exempt
false
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
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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