| Primary Device ID | 00817612020711 |
| NIH Device Record Key | 49e1b74f-c6e4-4768-8483-f77e0b1026ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dale PediPrints |
| Version Model Number | 241 |
| Catalog Number | 241 |
| Company DUNS | 001061233 |
| Company Name | DALE MEDICAL PRODUCTS, INC. |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817612020704 [Primary] |
| GS1 | 00817612020711 [Package] Contains: 00817612020704 Package: Box [10 Units] In Commercial Distribution |
| HIBCC | H84102411 [Previous] |
| CBH | Device, Fixation, Tracheal Tube |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-05-15 |
| Device Publish Date | 2019-02-19 |
| 00817612020742 | Dale PediPrints Tracheostomy Tube Holder, .75" wide, fits up to 9" neck. |
| 00817612020711 | Dale PediPrints Tracheostomy Tube Holder, 1" wide, fits up to 18" neck |
| H84102422 | Dale PediPrints Tracheostomy Tube Holder, .75" wide, fits up to 9" neck. |
| H84102412 | Dale PediPrints Tracheostomy Tube Holder, 1" wide, fits up to 18" neck |