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
| 05030267045952 - 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE | 2025-04-24 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE AND LIMB.1.6M |
| 05030267045884 - 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M | 2025-04-24 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M |
| 05030267001804 - TRACHEOSTOMY MASK, PAEDIATRIC | 2025-04-23 TRACHEOSTOMY MASK, PAEDIATRIC |
| 05030267098088 - PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M | 2025-04-23 PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M |
| 05030267165285 - 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE | 2025-04-23 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVEL ELBOW. 1.6M |
| 00816472022552 - Nose Clip with Padding | 2025-04-22 Nose Clip with Padding |
| 05030267161546 - 22mm Compact breathing system | 2025-04-22 22mm Compact breathing system with 3L bag, elbow, monitoring line, anesthetic face mask and HMEF >3m |
| 05030267161751 - 22mm Compact breathing system | 2025-04-22 22mm Compact breathing system with 3L bag, monitoring line, HMEF, and Clearlite facemask >3 m |
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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