| Primary Device ID | 00827002576254 |
| NIH Device Record Key | d0b4aeb8-3fd4-41c4-9289-5c55ede0a754 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Arndt |
| Version Model Number | G57625 |
| Catalog Number | C-CAE-14.0-70-LMA-01 |
| Company DUNS | 042823948 |
| Company Name | COOK 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 | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid extended exposure to light. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002576254 [Primary] |
| BTR | Tube, tracheal (w/wo connector) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2020-03-27 |
| 00827002132825 | Arndt Endobronchial Blocker Set With Spherical Balloon |
| 00827002132801 | Arndt Pediatric Endobronchial Blocker Set With Spherical Balloon |
| 00827002132795 | Arndt Pediatric Endobronchial Blocker Set With Spherical Balloon |
| 00827002082519 | Arndt Emergency Cricothyrotomy Catheter Set |
| 00827002576254 | Arndt Airway Exchange Catheter Set with Rapi-Fit Adapters |
| 00827002441200 | Arndt Endobronchial Blocker Set With Spherical Balloon |
| 00827002441170 | Arndt Endobronchial Blocker Set With Spherical Balloon |
| 00827002441149 | Arndt Endobronchial Blocker Set With Spherical Balloon |
| 00827002441118 | Arndt Pediatric Endobronchial Blocker Set With Spherical Balloon |
| 00827002441095 | Arndt Pediatric Endobronchial Blocker Set With Spherical Balloon |
| 00827002269071 | Arndt Endobronchial Blocker Set With Spherical Balloon |
| 00827002119208 | Arndt Airway Exchange Catheter |