INTERSURGICAL ECOLITE™, ADULT, MEDIUM CONCENTRATION OXYGEN MASK AND TUBE
GUDID 05030267165667
INTERSURGICAL ECOLITE™, ADULT, MEDIUM CONCENTRATION OXYGEN MASK AND TUBE WITH UNIVERSAL CONNECTOR, 2.1M
Intersurgical Incorporated
Rebreathing oxygen face mask| Primary Device ID | 05030267165667 |
| NIH Device Record Key | 4b5d3970-6c94-4273-9fd1-37bb4e42e824 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTERSURGICAL ECOLITE™, ADULT, MEDIUM CONCENTRATION OXYGEN MASK AND TUBE |
| Version Model Number | 1135017 |
| Company DUNS | 785952607 |
| Company Name | Intersurgical Incorporated |
| 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 | false |
| Device Combination Product | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05030267157853 [Primary] |
| GS1 | 05030267165667 [Package] Contains: 05030267157853 Package: [30 Units] In Commercial Distribution |
FDA Product Code
| BYG | Mask, Oxygen |
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 | 2023-11-17 |
| Device Publish Date | 2023-11-09 |
Devices Manufactured by Intersurgical Incorporated
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| 00816472022217 - Smoothbore breathing system without exhalation port, 22mm, 1.6m | 2025-02-11 Smoothbore breathing system without exhalation port, 22mm, 1.6m |
| 00816472022538 - Multipac® Anesthesia Breathing System | 2025-02-11 Multipac® Anesthesia Breathing System |
| 00816472023610 - Smoothbore circuit, 22mm | 2025-02-11 Smoothbore circuit, 22mm |
| 00816472023696 - Multipac Anesthesia Breathing Circuit | 2025-02-11 Multipac Anesthesia Breathing Circuit |
Trademark Results [INTERSURGICAL ECOLITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTERSURGICAL ECOLITE 86274433 4687510 Live/Registered |
Intersurgical Limited 2014-05-07 |
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