DISPIRO 02013
GUDID H671020131
UNIVERSAL CONNECTOR
UTAH MEDICAL PRODUCTS, INC.
Gasometer| Primary Device ID | H671020131 |
| NIH Device Record Key | 243892a5-1fdd-4849-aff2-0902e17a7570 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DISPIRO |
| Version Model Number | Universal Connector |
| Catalog Number | 02013 |
| Company DUNS | 094651270 |
| Company Name | UTAH MEDICAL PRODUCTS, INC. |
| Device Count | 50 |
| 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 | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
| Phone | 800-533-4984 |
| customer@utahmed.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H671020130 [Unit of Use] |
| HIBCC | H671020131 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K791177
FDA Product Code
| BZG | Spirometer, Diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-18 |
| Device Publish Date | 2016-09-22 |
On-Brand Devices [DISPIRO]
| H671020091 | UNIVERSAL MANIFOLD AND TRACH ADAPTOR |
| H671020021 | MANOMETER CONNECTOR PRESSURE CAP W/ 14" TUBING |
| H671020011 | 5 LITER STANDARD KIT W/ P/N 02002, 02009, 02020, & 02401 |
| H671020001 | 10 LITER STANDARD KIT W/ P/N 02002, 02009, 02020, & 02400 |
| H6719502452 | Disposable Spirometer System Kit with 02401, 02020, 02013 |
| H671025001 | STANDARD KIT W/ P/N 02002, 02009, & 02010, 02020, NO BAG |
| H671024611 | BULK PACK, 5 LITER COLLECTION BAG W/ 22MM CONNECTOR |
| H671024601 | BULK PACK, 10 LITER COLLECTION BAG W/ 22MM CONNECTOR |
| H671024511 | BULK PACK, 5 LITER COLLECTION BAG W/ UNIVERSAL CONNECTOR |
| H671024011 | BAG, 5 LITER W/ BAG KEEPER |
| H671024001 | BAG, 10 LITER W/ BAG KEEPER |
| H671020401 | 22 MM CONNECTOR W/ ONE-WAY VALVE |
| H671020201 | MOUTH PIECE W/ DOUBLE ONE-WAY VALVES |
| H671020131 | UNIVERSAL CONNECTOR |
Trademark Results [DISPIRO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DISPIRO 73419541 1280628 Dead/Cancelled |
Utah Medical Products, Inc. 1983-03-31 |
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