LoFric® Sense™ 4160850
GUDID 07333387021232
Single Use Urinary Catheter LoFric Sense Nelaton 15cm CH08 / Nelaton 6" 08FR
Wellspect AB
Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use| Primary Device ID | 07333387021232 |
| NIH Device Record Key | b44f2b59-152e-45f4-94c3-50b77a103f76 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LoFric® Sense™ |
| Version Model Number | 4160850 |
| Catalog Number | 4160850 |
| 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 | true |
| 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 | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 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 | 07333387021218 [Primary] |
| GS1 | 07333387021225 [Package] Contains: 07333387021218 Package: [30 Units] In Commercial Distribution |
| GS1 | 07333387021232 [Package] Contains: 07333387021225 Package: [4 Units] In Commercial Distribution |
| GS1 | 07392532085963 [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® Sense™]
| 07333387023335 | Single Use Urinary Catheter LoFric Sense Nelaton 15cm CH14 / Nelaton 6" 14FR |
| 07333387023083 | Single Use Urinary Catheter with salt solution. LoFric Sense, Nelaton 15cm CH14 / Nelaton 6" 14F |
| 07333387022611 | Single Use Urinary Catheter LoFric Sense Nelaton 15cm CH12 / Nelaton 6" 12FR |
| 07333387022369 | Single Use Urinary Catheter with salt solution. LoFric Sense, Nelaton 15cm CH12 / Nelaton 6" 12F |
| 07333387021638 | Single Use Urinary Catheter with salt solution. LoFric Sense, Nelaton 15cm CH10 / Nelaton 6" 10F |
| 07333387021232 | Single Use Urinary Catheter LoFric Sense Nelaton 15cm CH08 / Nelaton 6" 08FR |
| 07333387020990 | Single Use Urinary Catheter with salt solution. LoFric Sense, Nelaton 15cm CH08 / Nelaton 6" 08F |
| 07333387021898 | Single Use Urinary Catheter LoFric Sense Nelaton 15cm CH10 / Nelaton 6" 10FR |
Trademark Results [LoFric]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LOFRIC 73423764 1324299 Live/Registered |
Astra Meditec Aktiebolag 1983-04-29 |
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