FDA.reportPublic FDA data

MPROSAFE® Multi-sample Needle

Primary DI
26974481833762
Brand
MPROSAFE® Multi-sample Needle
Company
Guangzhou Improve Medical Instruments Co., Ltd.
Model
22G×1 1/2”
Catalog number
598422386
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
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
26974481833762PackageGS125In Commercial Distribution
66974481833760PackageGS1200In Commercial Distribution
06974481833751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697448183376226974481833762
6697448183376066974481833760
06974481833751069744818337516974481833751

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection tube holder/needleA sterile, hand-held cylindrical device with a pre-attached needle designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554555378
Device count
1
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
true
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
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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