Primary Device ID | 00848838018817 |
NIH Device Record Key | 156b24d9-c0a1-499f-a0b1-f4eb64906321 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | Y3462 |
Company DUNS | 065769564 |
Company Name | REMEL, INC. |
Device Count | 10 |
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 | false |
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 | false |
OTC Over-The-Counter | false |
Phone | 8002556730 |
ITechnicalSupport@remel.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00848838018817 [Primary] |
GS1 | 00848838099717 [Unit of Use] |
NGZ | Susceptibility Test Plate, Antifungal |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-24 |
00848838000010 - REMEL | 2024-04-17 Anaer (CDC) Blood Agar 15/PK |
00848838000607 - REMEL | 2024-04-17 Bile Esculin Azide Agar 15/PK |
00848838000614 - REMEL | 2024-04-17 Blood Agar,5% Sheep Blood 150/PK |
00848838000638 - REMEL | 2024-04-17 Blood Agar,5% Sheep Blood 15/PK |
00848838000980 - REMEL | 2024-04-17 Brucella Agar, LKV 10/PK |
00848838001154 - REMEL | 2024-04-17 Chocolate Agar 150/PK |
00848838001215 - REMEL | 2024-04-17 Chocolate Agar 15/PK |
00848838001352 - REMEL | 2024-04-17 Columbia CNA w/5% Sheep Blood 150/PK |