Primary Device ID | 00850038863111 |
NIH Device Record Key | b8acff19-c2de-4d6a-ac3c-f80840d183ab |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Directmed, Inc. |
Version Model Number | PME007NB |
Company DUNS | 969484237 |
Company Name | Directmed, Inc. |
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 | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850038863111 [Primary] |
FPA | Set, Administration, Intravascular |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-08 |
Device Publish Date | 2023-10-31 |
10850038863118 | EXTENSION SET 7" SMALLBORE |
10850038863101 | EXTENSION SET 7” SMALLBORE BONDED VALVE |
00850038863111 | EXTENSION SET 7" SMALLBORE |
00850038863104 | EXTENSION SET 7” SMALLBORE BONDED VALVE |
10850038863163 | Extension Set with 0.2um filter |
00850038863166 | Extension Set with 0.2um filter |
10850038863170 | Administration Set-Female Luer lock, 150µm Filter w/Male Luer Lock, Sterile |
00850038863173 | Administration Set-Female Luer lock, 150µm Filter w/Male Luer Lock, Sterile |