Primary Device ID | 00860011521266 |
NIH Device Record Key | f123d461-8cbf-41ea-915e-d492a01bbc2e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pylo Health |
Version Model Number | OX1-LTE |
Company DUNS | 116961530 |
Company Name | Prevounce Health, 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 | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860011521266 [Primary] |
DQA | Oximeter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-09-26 |
Device Publish Date | 2024-09-18 |
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00860011521259 | Blood Glucose Monitoring System Kit |
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00860011521235 | Pylo Lancing Device |
00860011521228 | Pylo Blood Glucose Test Strip |
00860011521211 | Pylo Control Solution |
00860011521204 | Pylo Blood Glucose Meter Device GL1-LTE |
00860011521266 | LTE connected spot measurement pulse oximeter |