FDA.reportPublic FDA data

micsafe

Primary DI
06971911291501
Brand
micsafe
Company
Jiangsu Micsafe Medical Tehcnology Co.,LTD.
Model
1
Device description
"BLOOD COLLECTION SET WITH HOLDER 20Gx3/4"""
Published
2023-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212019000Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for SingleJiangsu Micsafe Medical Technology Co., Ltd.2021-11-04JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971911291508PackageGS1100In Commercial Distribution
26971911291505PackageGS1500In Commercial Distribution
06971911291501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697191129150816971911291508
2697191129150526971911291505
06971911291501069719112915016971911291501

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.

Regulatory Flags#

DUNS number
554400604
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16971911292550micsafe 12023-05-31
16971911292567micsafe 12023-05-31
06971911290726micsafe 12023-05-31
06971911290733micsafe 12023-05-31
06971911290740micsafe 12023-05-31
06971911290757micsafe 12023-05-31
06971911290764micsafe 12023-05-31
06971911290771micsafe 12023-05-31
06971911291075micsafe 12023-05-31
06971911291082micsafe 12023-05-31
06971911291174micsafe 12023-05-31
06971911291181micsafe 12023-05-31
06971911291198micsafe 12023-05-31
06971911291518micsafe 12023-05-31
06971911291525micsafe 12023-05-31
06971911291532micsafe 12023-05-31
06971911291556micsafe 12023-05-31
06971911291563micsafe 12023-05-31
06971911291570micsafe 12023-05-31
06971911292089micsafe 12023-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16972857297791Easydrip PentaGlider Plus Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09
20192253036982MonojectCardinal Health 200, LLCFMI2026-07-09
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20192253037026MonojectCardinal Health 200, LLCFMI2026-07-09
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20192253037194MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037200MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037255MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037262MonojectCardinal Health 200, LLCFMI2026-07-09
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20192253038283MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038290MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038313MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038337MonojectCardinal Health 200, LLCFMI2026-07-09