SCIg60
GUDID 00817708023398
SCIg60 Infusion Pump Carrying Case
EMED TECHNOLOGIES CORPORATION
General-purpose infusion pump, mechanical, reusable| Primary Device ID | 00817708023398 |
| NIH Device Record Key | 42c58d71-3aca-498d-9518-7f9ea4ade3ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SCIg60 |
| Version Model Number | FP-0010032 |
| Company DUNS | 622637544 |
| Company Name | EMED TECHNOLOGIES CORPORATION |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817708023398 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142319
FDA Product Code
| PKP | Immunoglobulin G (Igg) Infusion System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-17 |
| Device Publish Date | 2020-08-07 |
Devices Manufactured by EMED TECHNOLOGIES CORPORATION
| 00817708023404 - VersaPump Infuser | 2023-12-26 The VersaPump Infuser is a reusable mechanical, non-electronic infusion pump that does not require batteries or any electrical s |
| 00817708022964 - AccuSert | 2022-11-01 OPTFlow Needle Inserter |
| 00817708022988 - AccuSert | 2022-11-01 SAF-SUB-Q Needle Inserter |
| 00817708020557 - SAF-Q | 2020-12-15 36" Single SUB-Q set with safety, 6mm needle and 24-gauge w/Dressing, Box of 10 |
| 00817708020571 - SAF-Q | 2020-12-15 36" Single SUB-Q set with safety, 6mm needle and 27-gauge w/Dressing, Box of 10 |
| 00817708020618 - SAF-Q | 2020-12-15 2" SUB-Q Single Lumen Tissue Infusion Set with safety, 27G Needle, 6mm needle w/Needle Free Injection Site, Box of 10 |
| 00817708020632 - SAF-Q | 2020-12-15 36" Single SUB-Q set with safety, 9mm needle and 24-gauge w/Dressing, Box 0f 10 |
| 00817708020670 - SAF-Q | 2020-12-15 36" Single SUB-Q set with safety, 9mm needle and 27-gauge w/Dressing, Box of 10 |
Trademark Results [SCIg60]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SCIG60 90474483 not registered Live/Pending |
EMED Technologies Corporation 2021-01-19 |
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