PULMO-PROTECT™ LUNG FUNCTION FILTER, FLEXIBLE MOUTHPIECE AND NOSE CLIP
GUDID 05030267135783
PULMO-PROTECT™ LUNG FUNCTION FILTER, FLEXIBLE MOUTHPIECE AND NOSE CLIP
Intersurgical Incorporated
Pulmonary function testing kit| Primary Device ID | 05030267135783 |
| NIH Device Record Key | 98fbc210-a7ee-4abd-974f-2d125b886244 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PULMO-PROTECT™ LUNG FUNCTION FILTER, FLEXIBLE MOUTHPIECE AND NOSE CLIP |
| Version Model Number | 1691012 |
| 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 | 05030267135776 [Primary] |
| GS1 | 05030267135783 [Package] Contains: 05030267135776 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
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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