SpeediCath 28702
GUDID 05708932698337
Catheter Gauge 12 FR/CH.
Coloplast A/S
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 | 05708932698337 |
| NIH Device Record Key | 40783c7b-0326-468a-99cf-e3ce53de2286 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpeediCath |
| Version Model Number | 28702 |
| Catalog Number | 28702 |
| Company DUNS | 305524696 |
| Company Name | Coloplast A/S |
| 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 | true |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Catheter Length | 34 Centimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Outer Diameter | 4 Millimeter |
| Catheter Length | 13.2 Inch |
| Catheter Working Length | 30 Centimeter |
| Catheter Working Length | 11.8 Inch |
| Device Size Text, specify | 0 |
| Catheter Length | 34 Centimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Outer Diameter | 4 Millimeter |
| Catheter Length | 13.2 Inch |
| Catheter Working Length | 30 Centimeter |
| Catheter Working Length | 11.8 Inch |
| Device Size Text, specify | 0 |
| Catheter Length | 34 Centimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Outer Diameter | 4 Millimeter |
| Catheter Length | 13.2 Inch |
| Catheter Working Length | 30 Centimeter |
| Catheter Working Length | 11.8 Inch |
| Device Size Text, specify | 0 |
| Catheter Length | 34 Centimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Outer Diameter | 4 Millimeter |
| Catheter Length | 13.2 Inch |
| Catheter Working Length | 30 Centimeter |
| Catheter Working Length | 11.8 Inch |
| Device Size Text, specify | 0 |
| Catheter Length | 34 Centimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Outer Diameter | 4 Millimeter |
| Catheter Length | 13.2 Inch |
| Catheter Working Length | 30 Centimeter |
| Catheter Working Length | 11.8 Inch |
| Device Size Text, specify | 0 |
| Catheter Length | 34 Centimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Outer Diameter | 4 Millimeter |
| Catheter Length | 13.2 Inch |
| Catheter Working Length | 30 Centimeter |
| Catheter Working Length | 11.8 Inch |
| Device Size Text, specify | 0 |
| Catheter Length | 34 Centimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Outer Diameter | 4 Millimeter |
| Catheter Length | 13.2 Inch |
| Catheter Working Length | 30 Centimeter |
| Catheter Working Length | 11.8 Inch |
| Device Size Text, specify | 0 |
| Catheter Length | 34 Centimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Outer Diameter | 4 Millimeter |
| Catheter Length | 13.2 Inch |
| Catheter Working Length | 30 Centimeter |
| Catheter Working Length | 11.8 Inch |
| Device Size Text, specify | 0 |
| Catheter Length | 34 Centimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Outer Diameter | 4 Millimeter |
| Catheter Length | 13.2 Inch |
| Catheter Working Length | 30 Centimeter |
| Catheter Working Length | 11.8 Inch |
| Device Size Text, specify | 0 |
| Catheter Length | 34 Centimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Outer Diameter | 4 Millimeter |
| Catheter Length | 13.2 Inch |
| Catheter Working Length | 30 Centimeter |
| Catheter Working Length | 11.8 Inch |
| Device Size Text, specify | 0 |
| Catheter Length | 34 Centimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Outer Diameter | 4 Millimeter |
| Catheter Length | 13.2 Inch |
| Catheter Working Length | 30 Centimeter |
| Catheter Working Length | 11.8 Inch |
| Device Size Text, specify | 0 |
| Catheter Length | 34 Centimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Outer Diameter | 4 Millimeter |
| Catheter Length | 13.2 Inch |
| Catheter Working Length | 30 Centimeter |
| Catheter Working Length | 11.8 Inch |
| Device Size Text, specify | 0 |
| Catheter Length | 34 Centimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Outer Diameter | 4 Millimeter |
| Catheter Length | 13.2 Inch |
| Catheter Working Length | 30 Centimeter |
| Catheter Working Length | 11.8 Inch |
| Device Size Text, specify | 0 |
| Catheter Length | 34 Centimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Outer Diameter | 4 Millimeter |
| Catheter Length | 13.2 Inch |
| Catheter Working Length | 30 Centimeter |
| Catheter Working Length | 11.8 Inch |
| Device Size Text, specify | 0 |
| Catheter Length | 34 Centimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Outer Diameter | 4 Millimeter |
| Catheter Length | 13.2 Inch |
| Catheter Working Length | 30 Centimeter |
| Catheter Working Length | 11.8 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05708932698320 [Primary] |
| GS1 | 05708932698337 [Package] Contains: 05708932698320 Package: Shipper Box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143182
FDA Product Code
| GBM | CATHETER, URETHRAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-11 |
| Device Publish Date | 2022-04-01 |
On-Brand Devices [SpeediCath]
| 05708932545716 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932545686 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932545648 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932545617 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932640466 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932640480 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932640497 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932639620 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932641173 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932641159 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932641135 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932641111 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932641081 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932641074 | SpeediCath Standard. Catheter with accessories. Nelaton. Female. 1 Ready to use coated catheter, |
| 05708932641050 | SpeediCath Standard. Catheter with accessories. Nelaton. Female. 1 Ready to use coated catheter, |
| 05708932641036 | SpeediCath Standard. Catheter with accessories. Nelaton. Female. 1 Ready to use coated catheter, |
| 05708932641012 | SpeediCath Standard. Catheter with accessories. Nelaton. Female. 1 Ready to use coated catheter, |
| 05708932640992 | SpeediCath Standard. Catheter with accessories. Nelaton. Female. 1 Ready to use coated catheter, |
| 05708932640978 | SpeediCath Standard. Catheter with accessories. Nelaton. Female. 1 Ready to use coated catheter, |
| 05708932545969 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932640947 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932640923 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932640909 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932640893 | SpeediCath Standard. Catheter with accessories. Nelaton. Male. 1 Ready to use coated catheter, s |
| 05708932640879 | SpeediCath Standard. Catheter with accessories. Nelaton. Male. 1 Ready to use coated catheter, s |
| 05708932640855 | SpeediCath Standard. Catheter with accessories. Nelaton. Male. 1 Ready to use coated catheter, s |
| 05708932640831 | SpeediCath Standard. Catheter with accessories. Nelaton. Male. 1 Ready to use coated catheter, s |
| 05708932640817 | SpeediCath Standard. Catheter with accessories. Nelaton. Male. 1 Ready to use coated catheter, s |
| 05708932640794 | SpeediCath Standard. Catheter with accessories. Nelaton. Male. 1 Ready to use coated catheter, s |
| 05708932640770 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932640749 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932640725 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932645850 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932640701 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932640688 | SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated cath |
| 05708932698337 | Catheter Gauge 12 FR/CH. |
Trademark Results [SpeediCath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPEEDICATH 75899446 2608545 Live/Registered |
Coloplast A/S 2000-01-19 |
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