Primary Device ID | 00822045000278 |
NIH Device Record Key | 3389c5b1-fcbd-402a-a159-dc77a2b8a613 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SAM IO Intraosseous Access System |
Version Model Number | IO705-1P-EN |
Company DUNS | 131084188 |
Company Name | SAM Medical Products |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 5036395474 |
quality@sammedical.com | |
Phone | 5036395474 |
quality@sammedical.com | |
Phone | 5036395474 |
quality@sammedical.com | |
Phone | 5036395474 |
quality@sammedical.com | |
Phone | 5036395474 |
quality@sammedical.com | |
Phone | 5036395474 |
quality@sammedical.com | |
Phone | 5036395474 |
quality@sammedical.com | |
Phone | 5036395474 |
quality@sammedical.com | |
Phone | 5036395474 |
quality@sammedical.com | |
Phone | 5036395474 |
quality@sammedical.com | |
Phone | 5036395474 |
quality@sammedical.com | |
Phone | 5036395474 |
quality@sammedical.com | |
Phone | 5036395474 |
quality@sammedical.com | |
Phone | 5036395474 |
quality@sammedical.com | |
Phone | 5036395474 |
quality@sammedical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00822045000278 [Primary] |
GS1 | 30822045000279 [Package] Package: Case [30 Units] In Commercial Distribution |
FMI | Needle, Hypodermic, Single Lumen |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-03-05 |
Device Publish Date | 2020-02-26 |
20822045000289 | SAM IO - 25mm Needle Assembly - 5 Pack |
30822045000293 | SAM IO - 45mm Needle Assembly - 5 Pack |
20822045000272 | SAM IO - 15mm Needle Assembly - 5 Pack |
10822045000329 | SAM IO - Adaptor - 1 Pack |
20822045000296 | SAM IO - 45mm Needle Assembly - 1 Pack |
10822045000282 | SAM IO - 25mm Needle Assembly - 1 Pack |
00822045000278 | SAM IO - 15 mm Needle Assembly - 1 Pack |
10822045000244 | SAM IO - Driver - 1 Pack |
30822045000309 | SAM IO Stabilizer - 5 Pack |
20822045000302 | SAM IO Stabilizer - 1 Pack |