| Primary Device ID | 05060460843710 |
| NIH Device Record Key | be2bd80f-53ac-4d42-8503-5030c92a2fd9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enteral |
| Version Model Number | DBISO-250 |
| Catalog Number | DBISO-250 |
| Company DUNS | 216643186 |
| Company Name | GBUK ENTERAL LIMITED |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060460843697 [Primary] |
| GS1 | 05060460843703 [Package] Contains: 05060460843697 Package: Box [20 Units] In Commercial Distribution |
| GS1 | 05060460843710 [Package] Contains: 05060460843703 Package: Case [6 Units] In Commercial Distribution |
| FFD | EVACUATOR, BLADDER, MANUALLY OPERATED |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-27 |
| Device Publish Date | 2022-10-19 |
| 05060590880937 | Enteral, Drainage Bag, PVC, Single Use 2000ml |
| 05060590880890 | Enteral, Drainage Bag, PVC, Single Use 1500ml |
| 05060590880869 | Enteral, Drainage Bag, PVC, Single Use 1000ml |
| 05060590880838 | Enteral, Drainage Bag, PVC, Single Use 500ml |
| 05060590880807 | Enteral, Drainage Bag, PVC, Single Use 250ml |
| 05060590889442 | Enteral ISOSAF Single Use Drainage Bag 1000ml |
| 05060590889428 | Enteral ISOSAF Single Use Drainage Bag 500ml |
| 05060590889398 | Enteral ISOSAF Single Use Drainage Bag 250ml |
| 05060590889022 | Enteral Single Use Bottle Transfer Cap ISO 80369-3 ENFit |
| 05060460848234 | Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 4 – 24 – 26mm |
| 05060460848203 | Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 3.5 – 19 – 23mm |
| 05060460848180 | Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 3 – 17 – 20.5mm |
| 05060460848159 | Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 2 – 14 – 16.5mm |
| 05060460848111 | Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 1 – 12-15mm |
| 05060460848098 | Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 3.5 – 19 – 23mm |
| 05060460848050 | Enteral, Drainage Bag, EVA, Single Use Without Clamp, 500ml |
| 05060460845714 | Enteral, Drainage Bag, EVA, Single Use 100ml |
| 05060460845653 | Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 4 – 24 – 26mm |
| 05060460845639 | Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 3 – 17 – 20.5mm |
| 05060460845592 | Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 2 – 14 – 16.5mm |
| 05060460845561 | Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 1 – 12-15mm |
| 05060460843765 | Enteral, Drainage Bag, EVA, Single Use 500ml |
| 05060460843741 | Enteral, Drainage Bag, EVA, Single Use 50ml |
| 05060460843710 | Enteral, Drainage Bag, EVA, Single Use 250ml |
| 05060460843680 | Enteral, Drainage Bag, EVA, Single Use 1000ml |
| 05060590883792 | Enteral, Syringe, ISOSAF™ and Push Fit Cap, Single Use 35ml |
| 05060590883549 | Enteral, Syringe, ISOSAF™ and Push Fit Cap, Single Use 60ml |
| 05060590883501 | Enteral, Syringe, ISOSAF™ and Push Fit Cap, Single Use 20ml |
| 05060590883488 | Enteral, Syringe, ISOSAF™ and Push Fit Cap, Single Use 12ml |
| 05060590883440 | Enteral, Syringe, ISOSAF™ and Push Fit Cap, Single Use 6ml Low Dose Tip |
| 05060590883419 | Enteral, Syringe, ISOSAF™ and Push Fit Cap, Single Use 3ml Low Dose Tip |
| 05060590883389 | Enteral, Syringe, ISOSAF™ and Push Fit Cap, Single Use 1ml Low Dose Tip |
| 05060460848265 | Enteral, Syringe Accessories, ENFit® Male Syringe Cap, Single Use 10/blister |
| 05060460845684 | Enteral, Syringe, CareTip Catheter Tip, Single Use 60ml |
| 05060460844007 | Enteral, Stoma Plug, ENPLUG, Single Patient Use 18, 20Fr x 7cm |
| 05060460843987 | Enteral, Stoma Plug, ENPLUG, Single Patient Use 10, 12, 14, 16Fr x 4cm |
| 05060460843963 | Enteral, Stoma Plug, ENPLUG, Single Patient Use 10, 12, 14, 16Fr x 7cm |
| 05060460843796 | Enteral, Syringe Accessories, ENFit® Male Syringe Cap, Single Use |
| 10850801006964 | Enteral, Drawing Up Device, Medicine Straw, Single Use 50mm |
| 05060590883761 | Enteral, Syringe, ISOSAF™, Single Use 35ml |
| 05060590883297 | Enteral, Syringe, NN single O ring, Single Use 60ml |
| 05060590883273 | Enteral, Syringe, NN single O ring, Single Use 20ml |
| 05060590883235 | Enteral, Syringe, NN single O ring, Single Use 10ml |
| 05060590883204 | Enteral, Syringe, NN single O ring, Single Use 5ml |
| 05060590883174 | Enteral, Syringe, NN single O ring, Single Use 3ml Low Dose Tip |
| 05060590883150 | Enteral, Syringe, NN single O ring, Single Use 1ml Low Dose Tip |
| 05060590882887 | Enteral, Syringe, ISOSAF™, Single Use 2.5ml Low Dose Tip |
| 05060590882795 | Enteral Nutricare Clear Flo Single Use Feeding Tubes 10Fr x 75cm |
| 05060590882771 | Enteral Nutricare Clear Flo Single Use Feeding Tubes 8Fr x 75cm |
| 05060590882740 | Enteral Nutricare Clear Flo Single Use Feeding Tubes 6Fr x 75cm |