LoFric® Primo™ 4101840
GUDID 07333387011479
Single Use Urinary Catheter LoFric Primo Nelaton 16" 18FR
Wellspect AB
Single-administration urethral catheterization kit, single-use| Primary Device ID | 07333387011479 |
| NIH Device Record Key | c7a63a19-debd-479b-880e-9a06e89593e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LoFric® Primo™ |
| Version Model Number | 41018 |
| Catalog Number | 4101840 |
| 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
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 French |
| Length | 16 Inch |
| Catheter Gauge | 18 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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07333387011462 [Package] Contains: 07333387043036 Package: [30 Units] In Commercial Distribution |
| GS1 | 07333387011479 [Package] Contains: 07333387011462 Package: [4 Units] In Commercial Distribution |
| GS1 | 07333387043036 [Primary] |
| GS1 | 07392532131639 [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® Primo™]
| 07333387015415 | Single Use Urinary Catheter LoFric Primo Coudé 16" 14FR |
| 07333387015163 | Single Use Urinary Catheter LoFric Primo Coudé 16" 12FR |
| 07333387014913 | Single Use Urinary Catheter LoFric Primo Coudé 16" 10FR |
| 07333387012933 | Single Use Urinary Catheter LoFric Primo Nelaton 8" 12FR |
| 07333387012186 | Single Use Urinary Catheter LoFric Primo Nelaton 8" 10FR Paediatric |
| 07333387015668 | Single Use Urinary Catheter LoFric Primo Coudé 16" 16FR |
| 07333387013961 | Single Use Urinary Catheter LoFric Primo Nelaton 6" 08FR |
| 07333387013213 | Single Use Urinary Catheter LoFric Primo Nelaton 8" 14FR |
| 07333387011226 | Single Use Urinary Catheter LoFric Primo Nelaton 16" 16FR |
| 07333387010960 | Single Use Urinary Catheter LoFric Primo Nelaton 16" 14FR |
| 07333387015910 | Single Use Urinary Catheter LoFric Primo Coudé 16" 18FR |
| 07333387014678 | Single Use Urinary Catheter LoFric Primo Nelaton 6" 14FR |
| 07333387014449 | Single Use Urinary Catheter LoFric Primo Nelaton 6" 12FR |
| 07333387014197 | Single Use Urinary Catheter LoFric Primo Nelaton 6" 10FR |
| 07333387013718 | Single Use Urinary Catheter LoFric Primo Nelaton 8" 18FR |
| 07333387013473 | Single Use Urinary Catheter LoFric Primo Nelaton 8" 16FR |
| 07333387012674 | Single Use Urinary Catheter LoFric Primo Nelaton 8" 10FR |
| 07333387012438 | Single Use Urinary Catheter LoFric Primo Nelaton 8" 08FR |
| 07333387011950 | Single Use Urinary Catheter LoFric Primo Nelaton 8" 08FR Paediatric |
| 07333387011714 | Single Use Urinary Catheter LoFric Primo Nelaton 8" 06FR Paediatric |
| 07333387011479 | Single Use Urinary Catheter LoFric Primo Nelaton 16" 18FR |
| 07333387010687 | Single Use Urinary Catheter LoFric Primo Nelaton 16" 12FR |
| 07333387010427 | Single Use Urinary Catheter LoFric Primo Nelaton 16" 10FR |
| 07333387010182 | Single Use Urinary Catheter LoFric Primo 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.