Primary Device ID | 00865064000164 |
NIH Device Record Key | f95630e7-d463-4a63-9007-f4bccc20358a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Enfasmart feversense Continuous monitoring thermometer |
Version Model Number | VV220 |
Company DUNS | 013311479 |
Company Name | VIVALNK, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
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 |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00865064000164 [Primary] |
FLL | Thermometer, Electronic, Clinical |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-08-30 |
Device Publish Date | 2018-07-30 |
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00860008259226 - Hydrogel Adhesive | 2022-09-22 Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of speci |
00860008259202 - Hydrogel Adhesive | 2022-02-21 Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of speci |
00860008259219 - Hydrogel Adhesive | 2022-02-21 Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of speci |
00865064000195 - Hydrogel Adhesive | 2022-02-21 Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of speci |
00865064000157 - Continuous ECG Platform | 2020-02-07 VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display |
00865064000188 - Hydrogel Adhesive | 2020-02-07 The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor. |
00865064000126 - Enfasmart feversense Adhesive Refill Pack | 2019-10-23 The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor. |