Primary Device ID | 50851809002499 |
NIH Device Record Key | f3af1100-c4f9-43d6-b3c0-88fd2bb14a15 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AquaFlate |
Version Model Number | 253 |
Catalog Number | 253 |
Company DUNS | 828918164 |
Company Name | HR PHARMACEUTICALS 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 | true |
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 | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com | |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com | |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com | |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com | |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com | |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com | |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com | |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com | |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com | |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com | |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com | |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com | |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com | |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com | |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com | |
Phone | +1(717)252-1110 |
sbenser@hrpharma.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00851809002494 [Primary] |
GS1 | 50851809002499 [Package] Contains: 00851809002494 Package: Case [400 Units] In Commercial Distribution |
EZL | CATHETER, RETENTION TYPE, BALLOON |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-05-29 |
Device Publish Date | 2023-05-19 |
50851809002871 | AquaFlate 5mL Pre-Filled Sterile Water Syringe |
50851809002512 | AquaFlate 10mL Pre-Filled Sterile Water Syringe |
50851809002499 | AquaFlate 3.5mL Pre-Filled Sterile Water Syringe |
50850025153985 | AquaFlate 30mL Wide Pre-Filled Sterile Water Syringe |
50850025153978 | AquaFlate 10mL Wide Pre-Filled Sterile Water Syringe |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AQUAFLATE 97466686 not registered Live/Pending |
Wiesman Holdings, LLC 2022-06-20 |