Primary Device ID | 00810000521579 |
NIH Device Record Key | 01039551-ed71-412e-a0b8-4d4689ed6ce5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PureClarity™ |
Version Model Number | D719 |
Catalog Number | D719 |
Company DUNS | 009900424 |
Company Name | PARKELL, 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 | false |
Device Combination Product | false |
Single Use | false |
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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 6312491134 |
customerservice@parkell.com | |
Phone | 6312491134 |
customerservice@parkell.com | |
Phone | 6312491134 |
customerservice@parkell.com | |
Phone | 6312491134 |
customerservice@parkell.com | |
Phone | 6312491134 |
customerservice@parkell.com | |
Phone | 6312491134 |
customerservice@parkell.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810000521579 [Primary] |
JRS | Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-12-23 |
Device Publish Date | 2024-12-13 |
00810000521647 | PureClarity™ Purification Filter - Installation Kit |
00810000521579 | PureClarity™ Waterline Purification Filter |