SafeTPoint SBCSBWOH2503412

GUDID 16971564466018

The Safety blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients, and the safety sheath is designed to aid in the reduction of accidental needlesticks.

Jiangsu Caina Medical Co.,Ltd

Blood collection set, invasive
Primary Device ID16971564466018
NIH Device Record Key992d25b3-e75e-490b-99c0-845556b7411a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafeTPoint
Version Model Number25G*3/4"*12"
Catalog NumberSBCSBWOH2503412
Company DUNS544543513
Company NameJiangsu Caina Medical Co.,Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Needle Gauge25 Gauge
Length0.75 Inch
Length12 Inch
Needle Gauge25 Gauge
Length0.75 Inch
Length12 Inch
Needle Gauge25 Gauge
Length0.75 Inch
Length12 Inch
Needle Gauge25 Gauge
Length0.75 Inch
Length12 Inch
Needle Gauge25 Gauge
Length0.75 Inch
Length12 Inch
Needle Gauge25 Gauge
Length0.75 Inch
Length12 Inch
Needle Gauge25 Gauge
Length0.75 Inch
Length12 Inch
Needle Gauge25 Gauge
Length0.75 Inch
Length12 Inch
Needle Gauge25 Gauge
Length0.75 Inch
Length12 Inch
Needle Gauge25 Gauge
Length0.75 Inch
Length12 Inch
Needle Gauge25 Gauge
Length0.75 Inch
Length12 Inch
Needle Gauge25 Gauge
Length0.75 Inch
Length12 Inch
Needle Gauge25 Gauge
Length0.75 Inch
Length12 Inch
Needle Gauge25 Gauge
Length0.75 Inch
Length12 Inch
Needle Gauge25 Gauge
Length0.75 Inch
Length12 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS106971564466011 [Primary]
GS116971564466018 [Package]
Contains: 06971564466011
Package: [50 Units]
In Commercial Distribution
GS126971564466015 [Package]
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-12
Device Publish Date2022-09-02

On-Brand Devices [SafeTPoint]

16971564466018The Safety blood collection sets are intended to be used with vacuum blood collection tube for v
16971564466001The Safety blood collection sets are intended to be used with vacuum blood collection tube for v
16971564465998The Safety blood collection sets are intended to be used with vacuum blood collection tube for v
16971564465912The Safety blood collection sets are intended to be used with vacuum blood collection tube for v

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