Primary Device ID | 10700812001208 |
NIH Device Record Key | 47fb342b-c278-472e-9fba-228709b73181 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Medegen Medical |
Version Model Number | H140-01 |
Catalog Number | H140-01 |
Company DUNS | 055527753 |
Company Name | MEDEGEN MEDICAL PRODUCTS, LLC |
Device Count | 50 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00700812001201 [Primary] |
GS1 | 10700812001208 [Unit of Use] |
FNP | Urinal |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-05-26 |
Device Publish Date | 2020-05-18 |
H3621872 - Medegen Medical products | 2023-08-18 Sharps: 23 Qt. Btl Red |
00673844000231 - Medegen Medical Products, LLC | 2021-01-22 Bag: Bio 11X14 1.2Ml Red Pr Rl Pre Pak 1 |
00673844000248 - Medegen Medical Products, LLC | 2021-01-22 Bag: Bio 23X23 1.1Mil Red Pr Rl Pre Pak |
00673844000255 - Medegen Medical Products, LLC | 2021-01-22 Bag: Bio 33X40 1.2Ml Red Pr 250/Cs |
00673844000262 - Medegen Medical Products, LLC | 2021-01-22 Bag: Bio 25X34 1.2Ml Red Pr 250/Cs |
00673844000279 - Medegen Medical Products, LLC | 2021-01-22 Bag: Bio 25X34 1.2Ml Red Pr Pre Pak 200/ |
00673844000286 - Medegen Medical Products, LLC | 2021-01-22 Bag: Bio 25X34 1.2Ml Red Pr Pre Pak 250/ |
00673844000293 - Medegen Medical Products, LLC | 2021-01-22 Bag: Bio 38X45 1.5Ml Red Pr 200/Cs |