PULMO-PROTECT™ LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP
GUDID 05030267160419
PULMO-PROTECT™ LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP
Intersurgical Incorporated
Pulmonary function testing kit| Primary Device ID | 05030267160419 |
| NIH Device Record Key | 6dff5740-13cd-409c-a023-fbe895f33ccd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PULMO-PROTECT™ LUNG FUNCTION FILTER, MOUTHPIECE AND NOSE CLIP |
| Version Model Number | 1691053 |
| Company DUNS | 785952607 |
| Company Name | Intersurgical Incorporated |
| 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 | 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 | 05030267160402 [Primary] |
| GS1 | 05030267160419 [Package] Contains: 05030267160402 Package: [30 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K013123
FDA Product Code
| BZG | Spirometer, Diagnostic |
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 | 2022-07-25 |
| Device Publish Date | 2022-07-15 |
Devices Manufactured by Intersurgical Incorporated
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| 00816472020558 - Breathing Circuit | 2025-02-11 Breathing Circuit, 22mm, nonconductive, single use, MRI Safe |
| 00816472020695 - Convenience Pack with 12" Flex Tube | 2025-02-11 Convenience Pack with 12" Flex Tube |
| 00816472021852 - Sentri Intersurgical EcoLite, adult, mask with CO2 monitoring line | 2025-02-11 Sentri Intersurgical EcoLite, adult, mask with CO2 monitoring line with universal connector tube, 1.8m |
| 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 [PULMO-PROTECT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PULMO-PROTECT 90454812 not registered Live/Pending |
Intersurgical Limited 2021-01-08 |
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