SAM Medical

GUDID 00850068519026

SAM IO Stabilizer

ZIEN MEDICAL TECHNOLOGIES, INC.

Catheter/tubing connection protector
Primary Device ID00850068519026
NIH Device Record Key34113e2c-b170-489c-a124-cb12383a3550
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAM Medical
Version Model NumberIO740
Company DUNS017535668
Company NameZIEN MEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100850068519002 [Primary]
GS100850068519019 [Package]
Contains: 00850068519002
Package: 5Pk Carton [5 Units]
In Commercial Distribution
GS100850068519026 [Package]
Contains: 00850068519002
Package: 1Pk Carton [1 Units]
In Commercial Distribution
GS110850068519016 [Package]
Contains: 00850068519019
Package: 5Pk Shipper [6 Units]
In Commercial Distribution
GS110850068519023 [Package]
Package: 1Pk Shipper [30 Units]
In Commercial Distribution

FDA Product Code

KMKDevice, Intravascular Catheter Securement

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-11
Device Publish Date2025-06-03

On-Brand Devices [SAM Medical]

00850068519118The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, dis
00850068519088The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, dis
00850068519057The SAM IO Intraosseous Access System provides intraosseous access in the proximal tibia, distal
00860412001572Repositionable Chest Tube (RCT) catheters intended for use in pleural fluid drainage.
10850068519221SAM IO - Adaptor
10850068519030SAM IO Driver
00850068519026SAM IO Stabilizer

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