SAM IO Intraosseous Access System

GUDID 00822045000278

SAM IO - 15 mm Needle Assembly - 1 Pack

SAM Medical Products

Intraosseous infusion kit
Primary Device ID00822045000278
NIH Device Record Key3389c5b1-fcbd-402a-a159-dc77a2b8a613
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAM IO Intraosseous Access System
Version Model NumberIO705-1P-EN
Company DUNS131084188
Company NameSAM Medical Products
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5036395474
Emailquality@sammedical.com
Phone5036395474
Emailquality@sammedical.com
Phone5036395474
Emailquality@sammedical.com
Phone5036395474
Emailquality@sammedical.com
Phone5036395474
Emailquality@sammedical.com
Phone5036395474
Emailquality@sammedical.com
Phone5036395474
Emailquality@sammedical.com
Phone5036395474
Emailquality@sammedical.com
Phone5036395474
Emailquality@sammedical.com
Phone5036395474
Emailquality@sammedical.com
Phone5036395474
Emailquality@sammedical.com
Phone5036395474
Emailquality@sammedical.com
Phone5036395474
Emailquality@sammedical.com
Phone5036395474
Emailquality@sammedical.com
Phone5036395474
Emailquality@sammedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100822045000278 [Primary]
GS130822045000279 [Package]
Package: Case [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-05
Device Publish Date2020-02-26

On-Brand Devices [SAM IO Intraosseous Access System]

20822045000289SAM IO - 25mm Needle Assembly - 5 Pack
30822045000293SAM IO - 45mm Needle Assembly - 5 Pack
20822045000272SAM IO - 15mm Needle Assembly - 5 Pack
10822045000329SAM IO - Adaptor - 1 Pack
20822045000296SAM IO - 45mm Needle Assembly - 1 Pack
10822045000282SAM IO - 25mm Needle Assembly - 1 Pack
00822045000278SAM IO - 15 mm Needle Assembly - 1 Pack
10822045000244SAM IO - Driver - 1 Pack
30822045000309SAM IO Stabilizer - 5 Pack
20822045000302SAM IO Stabilizer - 1 Pack

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