GENTLECATH
GUDID 70768455153809
GENTLECATH LOWFRIC TMNN CH10
CONVATEC, PURCHASING DEPARTMENT
Indwelling urethral drainage catheter Indwelling urethral drainage catheter Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial| Primary Device ID | 70768455153809 |
| NIH Device Record Key | 44b5131f-9e94-415a-bf67-3566ffab0405 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GENTLECATH |
| Version Model Number | 421908 |
| Company DUNS | 809784593 |
| Company Name | CONVATEC, PURCHASING DEPARTMENT |
| 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 | 1-800-422-8811 |
| cic@convatec.com | |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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| Phone | 1-800-422-8811 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00768455168545 [Package] Contains: 30768455153801 Package: Sample Pack [10 Units] In Commercial Distribution |
| GS1 | 30768455153801 [Primary] |
| GS1 | 50768455153805 [Package] Contains: 30768455153801 Package: Carton [30 Units] In Commercial Distribution |
| GS1 | 70768455153809 [Package] Contains: 50768455153805 Package: Case [8 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181206
FDA Product Code
| GBM | Catheter, Urethral |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-10-02 |
| Device Publish Date | 2019-02-22 |
On-Brand Devices [GENTLECATH]
| 00768455145607 | FEMALE CATHETER CH16X6.5 IN |
| 00768455145591 | FEMALE CATHETER CH14X6.5 IN |
| 00768455145584 | FEMALE CATHETER CH12X6.5 IN |
| 00768455145577 | FEMALE CATHETER CH10X6.5 IN |
| 00768455145560 | FEMALE CATHETER CH08X6.5 IN |
| 70768455153847 | GENTLECATH LOWFRIC TMNN CH18 |
| 70768455153830 | GENTLECATH LOWFRIC TMNN CH16 |
| 70768455153823 | GENTLECATH LOWFRIC TMNN CH14 |
| 70768455153816 | GENTLECATH LOWFRIC TMNN CH12 |
| 70768455153809 | GENTLECATH LOWFRIC TMNN CH10 |
| 70768455153793 | GENTLECATH LOWFRIC TMNN CH08 |
| 30768455143611 | FEMALE GENTLECATH TPE CH16X07 IN |
| 30768455143604 | FEMALE GENTLECATH TPE CH14X07 IN |
| 30768455143598 | FEMALE GENTLECATH TPE CH12X07 IN |
| 30768455143581 | FEMALE GENTLECATH TPE CH10X07 IN |
| 30768455143574 | FEMALE GENTLECATH TPE CH08X07 IN |
| 04026704582556 | CVT GENTLECATH CLOSED FEM CH14 |
| 04026704582549 | CVT GENTLECATH CLOSED SOFT CH14 |
| 04026704582532 | CVT GENTLECATH CLOSED RDRUB CH16 |
| 04026704582525 | CVT GENTLECATH CLOSED RDRUB CH14 |
| 04026704582518 | CVT GENTLECATH CLOSED TMNN CH16 |
| 04026704582501 | 421434 |
| 04026704582495 | CVT GENTLECATH CLOSED TMNN CH12 |
| 04026704582488 | CVT GENTLECATH CLOSED CH16 |
| 04026704582471 | CVT GENTLECATH CLOSED CH14 |
| 04026704582464 | CVT GENTLECATH CLOSED CH12 |
| 04026704582457 | CVT GENTLECATH CLOSED CH10 |
| 04026704582440 | CVT GENTLECATH CLOSED CH08 |
| 04026704582433 | CVT GENTLECATH CLOSED FEM CH14 KIT |
| 04026704582426 | CVT GENTLECATH CLOSED RDRUBTMNN CH14 KIT |
| 04026704582419 | CVT GENTLECATH CLOSED RDRUB CH16 KIT |
| 04026704582402 | CVT GENTLECATH CLOSED RDRUB CH14 KIT |
| 04026704582396 | CVT GENTLECATH CLOSED RDRUB CH12 KIT |
| 04026704582389 | CVT GENTLECATH CLOSED TMNN CH16 KIT |
| 04026704582372 | CVT GENTLECATH CLOSED TMNN CH14 KIT |
| 04026704582365 | CVT GENTLECATH CLOSED TMNN CH12 KIT |
| 04026704582358 | CVT GENTLECATH CLOSED SOFT CH14 KIT |
| 04026704582341 | CVT GENTLECATH CLOSED SOFT CH12 KIT |
| 04026704582334 | CVT GENTLECATH CLOSED CH18 KIT |
| 04026704582327 | CVT GENTLECATH CLOSED CH16 KIT |
| 04026704582310 | CVT GENTLECATH CLOSED CH14 KIT |
| 04026704582303 | CVT GENTLECATH CLOSED CH12 KIT |
| 04026704582297 | CVT GENTLECATH CLOSED CH10 KIT |
| 04026704582280 | CVT GENTLECATH CLOSED CH08 KIT |
| 04026704582273 | CVT GENTLECATH CLOSED CH06 KIT |
| 04026704582266 | CVT GENTLECATH IC CATH INSERT SUPPLIES KIT |
| 00768455198948 | GENTLECATH AIR MEN COUDE CH18 1X10 US |
| 00768455198917 | GENTLECATH AIR MEN COUDE CH16 1X10 US |
| 00768455198887 | GENTLECATH AIR MEN COUDE CH14 1X10 US |
| 00768455198856 | GENTLECATH AIR MEN COUDE CH12 1X10 US |
Trademark Results [GENTLECATH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENTLECATH 85415846 4335634 Live/Registered |
Unomedical A/S 2011-09-06 |
 GENTLECATH 85211109 4376858 Live/Registered |
Unomedical A/S 2011-01-05 |
 GENTLECATH 79269368 not registered Live/Pending |
ConvaTec Inc. 2019-08-23 |
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