Primary Device ID | 00817369020002 |
NIH Device Record Key | de7117ef-554b-4242-8d7d-5bd572bfa8f4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NormaTec Pulse |
Version Model Number | JMS4 |
Catalog Number | 10100 |
Company DUNS | 111448069 |
Company Name | NORMATEC INDUSTRIES LP |
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 | true |
Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 19 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817369020002 [Primary] |
IRP | Massager, Powered Inflatable Tube |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-13 |
00810050281294 - NormaTec | 2023-06-26 |
00810050281720 - NormaTec | 2023-06-26 |
00810050281768 - NormaTec | 2023-06-26 |
00810050281782 - NormaTec | 2023-06-26 |
00810050281805 - NormaTec | 2023-06-26 |
00810050281829 - NormaTec | 2023-06-26 |
00810050281836 - NormaTec | 2023-06-26 |
00810050281881 - NormaTec | 2023-06-26 |