Primary Device ID | 20814247020288 |
NIH Device Record Key | 8d97ebef-8ae7-4483-a2ce-1fad790c8022 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Koala Toco® |
Version Model Number | KDT-1000 |
Company DUNS | 809524291 |
Company Name | CLINICAL INNOVATIONS, 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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 | 00814247020284 [Primary] |
GS1 | 10814247020281 [Package] Contains: 00814247020284 Package: [10 Units] In Commercial Distribution |
GS1 | 20814247020288 [Package] Contains: 10814247020281 Package: [4 Units] In Commercial Distribution |
HFM | Monitor, Uterine Contraction, External (For Use In Clinic) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-01 |
10814247021196 - FSE | 2023-10-05 Fetal Spiral Electrode |
00814247021205 - FSE Cables | 2023-10-05 DECG Reusable Legplate Adapter Cable |
10814247020120 - babyLance | 2023-04-24 Preemie (Pink/White) 0.85 mm depth, Safety Heelstick |
10814247020168 - babyLance | 2023-04-24 Micropreemie (Yellow/Green) 0.60 mm depth, Safety Heelstick |
10814247020182 - babyLance | 2023-04-24 Newborn (Blue/Green) 1.0 mm depth, Safety Heelstick |
10814247021127 - ABBy | 2023-04-24 ABBy Panniculus Retractor - 05 Regular |
10814247021134 - ABBy | 2023-04-24 ABBy Panniculus Retractor - 05 Extra Large |
10814247021141 - ABBy | 2023-04-24 ABBy Panniculus Retractor - 10 Regular |