LoFric® Hydro-Kit™ 42316403
GUDID 07333387019307
Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 16FR
Wellspect AB
Single-administration urethral catheterization kit, single-use| Primary Device ID | 07333387019307 |
| NIH Device Record Key | cf508533-e056-4ff4-a958-10892351895b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LoFric® Hydro-Kit™ |
| Version Model Number | 42316 |
| Catalog Number | 42316403 |
| Company DUNS | 351118942 |
| Company Name | Wellspect 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
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
| Catheter Gauge | 16 French |
| Length | 8 Inch |
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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07333387019307 [Package] Contains: 07333387042916 Package: [30 Units] In Commercial Distribution |
| GS1 | 07333387019314 [Package] Package: [2 Units] In Commercial Distribution |
| GS1 | 07333387042916 [Primary] |
| GS1 | 07392532250590 [Previous] |
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 | 2023-10-03 |
| Device Publish Date | 2023-09-25 |
On-Brand Devices [LoFric® Hydro-Kit™]
| 07333387020556 | Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 16FR |
| 07333387017549 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 18FR |
| 07333387017808 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 08FR Paediatric |
| 07333387020808 | Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 18FR |
| 07333387020303 | Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 14FR |
| 07333387020068 | Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 12FR |
| 07333387017303 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 16FR |
| 07333387016832 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 12FR |
| 07333387019062 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 14FR |
| 07333387017068 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 14FR |
| 07333387019819 | Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 10FR |
| 07333387019567 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 18FR |
| 07333387019307 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 16FR |
| 07333387018805 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 12FR |
| 07333387018560 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 10FR |
| 07333387018317 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 08FR |
| 07333387018058 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 10FR Paediatric |
| 07333387016597 | Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 10FR |
| 07333387016351 | 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.