| Primary Device ID | 00850010197678 |
| NIH Device Record Key | bcc118a2-62ae-452e-8f43-d21ad39c49a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KIT, Rx, LACTULOSE, SIBO, 10T #8024 |
| Version Model Number | QT04260 |
| Catalog Number | QT04260 |
| Company DUNS | 874498744 |
| Company Name | QUINTRON INSTRUMENT COMPANY, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850010197678 [Primary] |
| NNI | Container, Specimen, Non-Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-23 |
| Device Publish Date | 2023-03-15 |
| 00850010197982 - SUGAR, Rx, LACTULOSE, 10 GM SYRUP, USP | 2024-03-26 |
| 00850010197937 - LOANER ALVEOVAC EXTRACTOR | 2023-03-27 |
| 00850010197944 - EXTRACTOR REPAIR | 2023-03-27 |
| 00850010197920 - EASYSAMPLER ASM, 793275 | 2023-03-24 |
| 00850010197906 - BT GC LOANER SC | 2023-03-24 |
| 00850010197913 - BREATHTRACKER SERIES REPAIR | 2023-03-24 |
| 00850010197005 - AlveoSampler | 2023-03-23 KIT, ALVEOSAMPLER ONLY, NO SUBSTRATE |
| 00850010197012 - GaSampler Bag, Single-Patient | 2023-03-23 BAG, COLLECTION, GASAMPLER, SINGLE PATIENT |