| Primary Device ID | 10827002472850 |
| NIH Device Record Key | 404be157-3e43-4f06-acc2-cbb926acc899 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Entuit |
| Version Model Number | G47285 |
| Catalog Number | C-ENTUIT-16-M-ENF |
| Company DUNS | 042823948 |
| Company Name | COOK INCORPORATED |
| 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 | true |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10827002472850 [Primary] |
| PRR | Feeding tube kit |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-31 |
| Device Publish Date | 2020-08-21 |
| 00827002344440 | Entuit Start Initial Placement Gastrostomy Set |
| 00827002344433 | Entuit Start Initial Placement Gastrostomy Set |
| 00827002344426 | Entuit Start Initial Placement Gastrostomy Set |
| 00827002355705 | Entuit Secure Gastrointestinal Suture Anchor Set |
| 00827002355699 | Entuit Secure Gastrointestinal Suture Anchor Set |
| 00827002355637 | Entuit Secure Adjustable Gastrointestinal Suture Anchor Set |
| 00827002355620 | Entuit Secure Adjustable Gastrointestinal Suture Anchor Set |
| 10827002472911 | Entuit Gastrostomy Set |
| 10827002472904 | Entuit Gastrostomy Set |
| 10827002472898 | Entuit Gastrostomy Set |
| 10827002472881 | Entuit Gastrostomy Set |
| 10827002472874 | Entuit Gastrostomy Set with ENFit Connection |
| 10827002472867 | Entuit Gastrostomy Set with ENFit Connection |
| 10827002472850 | Entuit Gastrostomy Set with ENFit Connection |
| 10827002472843 | Entuit Gastrostomy Set with ENFit Connection |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENTUIT 85830517 4700311 Live/Registered |
Cook Medical Technologies LLC 2013-01-23 |