THERMAGARD P20001H
GUDID 00612223057053
NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER
PEGASUS RESEARCH CORPORATION
Nebulizing system, heated| Primary Device ID | 00612223057053 |
| NIH Device Record Key | c91a2c92-9053-4c78-a047-847188051a07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | THERMAGARD |
| Version Model Number | 5705 |
| Catalog Number | P20001H |
| Company DUNS | 185432994 |
| Company Name | PEGASUS RESEARCH 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 | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Outer Diameter | 4 Inch |
| Outer Diameter | 4 Inch |
| Outer Diameter | 4 Inch |
| Outer Diameter | 4 Inch |
| Outer Diameter | 4 Inch |
| Outer Diameter | 4 Inch |
| Height | 4.5 Inch |
| Weight | 3 Pound |
| Outer Diameter | 4 Inch |
| Height | 4.5 Inch |
| Weight | 3 Pound |
| Outer Diameter | 4 Inch |
| Height | 4.5 Inch |
| Weight | 3 Pound |
| Outer Diameter | 4 Inch |
| Height | 4.5 Inch |
| Weight | 3 Pound |
| Outer Diameter | 4 Inch |
| Height | 4.5 Inch |
| Weight | 3 Pound |
| Outer Diameter | 4 Inch |
| Height | 4.5 Inch |
| Weight | 3 Pound |
| Outer Diameter | 4 Inch |
| Height | 4.5 Inch |
| Weight | 3 Pound |
| Outer Diameter | 4 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00612223057053 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K880473
FDA Product Code
| CAF | Nebulizer (Direct Patient Interface) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
Devices Manufactured by PEGASUS RESEARCH CORPORATION
| 00612223060008 - PEGASUS | 2021-09-27 FLO2 HIGH FLOW OXYGEN DILUTER, ADULT KIT |
| 00612223060503 - PEGASUS | 2021-09-27 FLO2 HIGH FLOW OXYGEN DILUTER |
| 00612223061005 - PEGASUS | 2021-09-27 FLO2 HIGH FLOW OXYGEN DILUTER, PEDIATRIC KIT |
| 00612223062002 - PEGASUS | 2021-09-27 FLO2 STANDARD FLOW OXYGEN DILUTER, ADULT KIT |
| 00612223062507 - PEGASUS | 2021-09-27 FLO2 STANDARD FLOW OXYGEN DILUTER |
| 00612223063009 - PEGASUS | 2021-09-27 FLO2 STANDARD FLOW OXYGEN DILUTER, PEDIATRIC KIT |
| 00612223700010 - MISTIC | 2021-09-27 NEBULIZER,BARREL REUSABLE BOTTLE 1000ML |
| 00612223701000 - PEGASUS | 2021-09-27 NEBULIZER HEATER ADAPTER GASKET |
Trademark Results [THERMAGARD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THERMAGARD 86869812 not registered Dead/Abandoned |
Lanco Manufacturing Corporation 2016-01-08 |
 THERMAGARD 74195414 1899754 Live/Registered |
TELEFLEX MEDICAL INCORPORATED 1991-08-16 |
 THERMAGARD 74148340 1676818 Dead/Cancelled |
ThermaGard, Inc. 1991-03-18 |
 THERMAGARD 72280250 0862814 Dead/Expired |
H. K. PORTER COMPANY, INC. 1967-09-13 |
 THERMAGARD 72200568 0807135 Dead/Expired |
ALLIED THERMAL CORPORATION 1964-08-25 |
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