Primary Device ID | 00815947020475 |
NIH Device Record Key | e9c70910-4334-4402-9330-35c44984ded6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cure Medical Catheter Insertion Kit |
Version Model Number | K2 |
Company DUNS | 070643426 |
Company Name | CURE MEDICAL LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
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 | 1-800-422-8811 |
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Device Issuing Agency | Device ID |
---|---|
GS1 | 00815947020475 [Primary] |
GS1 | 10815947020472 [Package] Package: Case [90 Units] In Commercial Distribution |
GS1 | 20815947020479 [Package] Package: Case [100 Units] In Commercial Distribution |
OHR | Catheter Care Tray |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-04-09 |
Device Publish Date | 2016-09-24 |
00815947020475 | Catheter Insertion Kit |
10815947020465 | Catheter Insertion Kit |