LoFric® Hydro-Kit™ 42008403
GUDID 07392532247255
Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 08FR
Dentsply Ih AB
Single-administration urethral catheterization kit, single-use| Primary Device ID | 07392532247255 |
| NIH Device Record Key | 4afbef7f-4528-4685-9e20-0eaedc4d26e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LoFric® Hydro-Kit™ |
| Version Model Number | 42008 |
| Catalog Number | 42008403 |
| Company DUNS | 354059073 |
| Company Name | Dentsply Ih AB |
| 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 | false |
| Expiration Date | true |
| 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
Device Dimensions
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
| Length | 16 Inch |
| Catheter Gauge | 8 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07392532247248 [Package] Contains: 07392532250477 Package: [30 Units] In Commercial Distribution |
| GS1 | 07392532247255 [Package] Contains: 07392532247248 Package: Transport Packaging [2 Units] In Commercial Distribution |
| GS1 | 07392532250477 [Primary] |
FDA Product Code
| EZD | CATHETER, STRAIGHT |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-14 |
| Device Publish Date | 2020-12-04 |
On-Brand Devices [LoFric® Hydro-Kit™]
| 07392532175060 | Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 18FR |
| 07392532175039 | Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 16FR |
| 07392532175008 | Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 14FR |
| 07392532174971 | Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 12FR |
| 07392532174940 | Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 10FR |
| 07392532155321 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 18FR |
| 07392532155291 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 16FR |
| 07392532155178 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 08FR |
| 07392532111709 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 18FR |
| 07392532111679 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 16FR |
| 07392532111631 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 14FR |
| 07392532092480 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 12FR |
| 07392532111587 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 10FR |
| 07392532111549 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 08FR |
| 07392532111501 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 10FR Paediatric |
| 07392532111464 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 08FR Paediatric |
| 07392532155260 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 14FR |
| 07392532084034 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 12FR |
| 07392532155208 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 10FR |
| 07392532247804 | Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 18FR |
| 07392532247774 | Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 16FR |
| 07392532247743 | Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 14FR |
| 07392532247729 | Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 12FR |
| 07392532247699 | Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 10FR |
| 07392532247668 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 18FR |
| 07392532247637 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 16FR |
| 07392532247606 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 14FR |
| 07392532247576 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 12FR |
| 07392532247521 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 10FR |
| 07392532247491 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 08FR |
| 07392532247453 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 10FR Paediatric |
| 07392532247439 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 08FR Paediatric |
| 07392532247408 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 18FR |
| 07392532247361 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 16FR |
| 07392532247347 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 14FR |
| 07392532247316 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 12FR |
| 07392532247279 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 10FR |
| 07392532247255 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 08FR |
Trademark Results [LoFric]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LOFRIC 73423764 1324299 Live/Registered |
Astra Meditec Aktiebolag 1983-04-29 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.