Primary Device ID | 10073796638006 |
NIH Device Record Key | e4fb52f3-0ebc-46fc-b7c6-e523b376b720 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Omron Total Power + Heat TENS Unit |
Version Model Number | PM800 |
Catalog Number | PM800 |
Company DUNS | 054318779 |
Company Name | Omron Healthcare, 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 | true |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 1-800-634-4350 |
ohiquality@omron.com |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00073796638009 [Primary] |
GS1 | 10073796638006 [Package] Contains: 00073796638009 Package: Case [12 Units] In Commercial Distribution |
GS1 | 50073796638004 [Package] Contains: 00073796638009 Package: Carton [3 Units] In Commercial Distribution |
NYN | Stimulator, Electrical, Transcutaneous, For Arthritis |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-11-07 |
Device Publish Date | 2019-05-06 |
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