GBUK PFS-10DSU

GUDID 06971564461108

10 ml XS Prefilled saline syringe 0.9%Sodium Chloride(0.9% Na Cl), USP

Jiangsu Caina Medical Co.,Ltd

Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Primary Device ID06971564461108
NIH Device Record Key8c3dcff2-e1d4-4348-991a-bfe6450c22c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameGBUK
Version Model Number10mL
Catalog NumberPFS-10DSU
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106971564461108 [Primary]
GS116971564461105 [Package]
Package: [30 Units]
In Commercial Distribution
GS126971564461102 [Package]
Package: [180 Units]
In Commercial Distribution
GS136971564461109 [Package]
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NGTSaline, Vascular Access Flush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-22
Device Publish Date2025-05-14

On-Brand Devices [GBUK]

0697156446297610ml XS Prefilled saline syringe 0.9%Sodium Chloride(0.9%NaCl),USP
1697156446113610 ml SP Prefilled saline syringe 0.9%Sodium Chloride(0.9%Na Cl)
169715644611295ml SP Prefilled saline syringe 0.9%Sodium Chloride(0.9%Na Cl),USP
069715644611153 ml SP Prefilled saline syringe 0.9%Sodium Chloride(0.9%Na Cl),USP
0697156446110810 ml XS Prefilled saline syringe 0.9%Sodium Chloride(0.9% Na Cl), USP

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