Primary Device ID | 00850015884269 |
NIH Device Record Key | 8c9928d7-c0d3-4e1c-ae74-3f228fca42bc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | easycare |
Version Model Number | 4818-62502 |
Catalog Number | 4818-62502 |
Company DUNS | 080160207 |
Company Name | SYNCHRONIS 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850015884252 [Primary] |
GS1 | 00850015884269 [Package] Contains: 00850015884252 Package: [100 Units] In Commercial Distribution |
LRS | I.V. Start Kit |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-08-21 |
Device Publish Date | 2020-08-13 |
00850015884184 | IV Start Kit w/3M™ Tegaderm™ #1683 Adv Securement & ChloraPrep™ 1mL |
00850015884177 | IV Start Kit w/3M™ Tegaderm™ #1614 w/Notch & ChloraPrep™ 1mL |
00850015884160 | IV Start Kit w/3M™ Tegaderm™ #1633 Split Tail & PDI Prevantics® Swab |
00850015884153 | IV Start Kit w/3M™ Tegaderm™ #1624 & PDI Prevantics® Swab |
00850015884269 | IV Start Kit w/18ga Safety Cath |
00850015884610 | Safety Subcutaneous Hydration Kit (HydoDermoClysis) |