Primary Device ID | 00840682104951 |
NIH Device Record Key | bbc5f664-40e1-487d-adaa-9443c679e897 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | S4-10-D |
Company DUNS | 078863378 |
Company Name | GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC |
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 | true |
OTC Over-The-Counter | false |
Phone | +1(800)437-1171 |
xx@xx.xx |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840682104951 [Primary] |
IYO | System, imaging, pulsed echo, ultrasonic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-08-01 |
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