LoFric® Origo™ 4471240
GUDID 07333387054353
Single Use Urinary Catheter with salt solution. LoFric Origo Coudé FX Male 40cm CH12 / Coudé FX 16" 12FR, Sterile device.
Wellspect AB
Single-administration urethral catheterization kit, single-use| Primary Device ID | 07333387054353 |
| NIH Device Record Key | f1745f02-57df-4681-b105-77d0be34da9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LoFric® Origo™ |
| Version Model Number | 44712 |
| Catalog Number | 4471240 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(877)456-3742 |
| info-lofric-usa@wellspect.com | |
| Phone | +1(877)456-3742 |
| info-lofric-usa@wellspect.com | |
| Phone | +1(877)456-3742 |
| info-lofric-usa@wellspect.com | |
| Phone | +1(877)456-3742 |
| info-lofric-usa@wellspect.com | |
| Phone | +1(877)456-3742 |
| info-lofric-usa@wellspect.com | |
| Phone | +1(877)456-3742 |
| info-lofric-usa@wellspect.com | |
| Phone | +1(877)456-3742 |
| info-lofric-usa@wellspect.com | |
| Phone | +1(877)456-3742 |
| info-lofric-usa@wellspect.com | |
| Phone | +1(877)456-3742 |
| info-lofric-usa@wellspect.com | |
| Phone | +1(877)456-3742 |
| info-lofric-usa@wellspect.com | |
| Phone | +1(877)456-3742 |
| info-lofric-usa@wellspect.com | |
| Phone | +1(877)456-3742 |
| info-lofric-usa@wellspect.com | |
| Phone | +1(877)456-3742 |
| info-lofric-usa@wellspect.com | |
| Phone | +1(877)456-3742 |
| info-lofric-usa@wellspect.com |
Device Dimensions
| Catheter Gauge | 12 French |
| Length | 16 Inch |
| Catheter Gauge | 12 French |
| Length | 16 Inch |
| Catheter Gauge | 12 French |
| Length | 16 Inch |
| Catheter Gauge | 12 French |
| Length | 16 Inch |
| Catheter Gauge | 12 French |
| Length | 16 Inch |
| Catheter Gauge | 12 French |
| Length | 16 Inch |
| Catheter Gauge | 12 French |
| Length | 16 Inch |
| Catheter Gauge | 12 French |
| Length | 16 Inch |
| Catheter Gauge | 12 French |
| Length | 16 Inch |
| Catheter Gauge | 12 French |
| Length | 16 Inch |
| Catheter Gauge | 12 French |
| Length | 16 Inch |
| Catheter Gauge | 12 French |
| Length | 16 Inch |
| Catheter Gauge | 12 French |
| Length | 16 Inch |
| Catheter Gauge | 12 French |
| Length | 16 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07333387052953 [Primary] |
| GS1 | 07333387054346 [Package] Contains: 07333387052953 Package: [30 Units] In Commercial Distribution |
| GS1 | 07333387054353 [Package] Contains: 07333387054346 Package: [4 Units] In Commercial Distribution |
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 | 2025-08-04 |
| Device Publish Date | 2025-07-25 |
On-Brand Devices [LoFric® Origo™]
| 07333387007922 | Single Use Urinary Catheter with salt solution. LoFric Origo, Tiemann 40cm CH16 / Coudé 16" 16F |
| 07333387007021 | Single Use Urinary Catheter with salt solution. LoFric Origo, Tiemann 40cm CH12 / Coudé 16" 12F |
| 07333387006451 | Single Use Urinary Catheter with salt solution. LoFric Origo, Tiemann 40cm CH10 / Coudé 16" 10F |
| 07333387007472 | Single Use Urinary Catheter with salt solution. LoFric Origo, Tiemann 40cm CH14 / Coudé 16" 14F |
| 07333387008349 | Single Use Urinary Catheter with salt solution. LoFric Origo, Tiemann 40cm CH18 / Coudé 16" 18F |
| 07333387006161 | Single Use Urinary Catheter with salt solution. LoFric Origo, Nelaton 40cm CH18 / Nelaton 16" 18 |
| 07333387003771 | Single Use Urinary Catheter with salt solution. LoFric Origo, Nelaton 30cm CH12 / Nelaton 12" 12 |
| 07333387005553 | Single Use Urinary Catheter with salt solution. LoFric Origo, Nelaton 40cm CH16 / Nelaton 16" 16 |
| 07333387005232 | Single Use Urinary Catheter with salt solution. LoFric Origo, Nelaton 40cm CH14 / Nelaton 16" 14 |
| 07333387004730 | Single Use Urinary Catheter with salt solution. LoFric Origo, Nelaton 40cm CH12 / Nelaton 16" 12 |
| 07333387002668 | Single Use Urinary Catheter with salt solution. LoFric Origo, Nelaton 30cm CH08 / Nelaton 12" 08 |
| 07333387004228 | Single Use Urinary Catheter with salt solution. LoFric Origo, Nelaton 40cm CH10 / Nelaton 16" 10 |
| 07333387003306 | Single Use Urinary Catheter with salt solution. LoFric Origo, Nelaton 30cm CH10 / Nelaton 12" 10 |
| 07333387009193 | Single Use Urinary Catheter with salt solution. LoFric Origo, Flexible 40cm CH14 / Straight Oliv |
| 07333387008769 | Single Use Urinary Catheter with salt solution. LoFric Origo, Flexible 40cm CH12 / Straight Oliv |
| 07333387054421 | Single Use Urinary Catheter with salt solution. LoFric Origo Coudé FX Male 40cm CH16 / Coudé F |
| 07333387054377 | Single Use Urinary Catheter with salt solution. LoFric Origo Coudé FX Male 40cm CH14 / Coudé F |
| 07333387054353 | Single Use Urinary Catheter with salt solution. LoFric Origo Coudé FX Male 40cm CH12 / Coudé F |
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.