DEL-CLAMP®
GUDID 20840861100631
DEL-CLAMP®
Fresenius Medical Care Holdings, Inc.
Peritoneal dialysis system tubing set| Primary Device ID | 20840861100631 |
| NIH Device Record Key | 80f5f85e-9186-42bd-9f91-d88023ad53c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DEL-CLAMP® |
| Version Model Number | 029-03001 |
| Company DUNS | 958291411 |
| Company Name | Fresenius Medical Care Holdings, Inc. |
| 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 | false |
| 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)323-5188 |
| xxx@xxx.xxx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840861100637 [Primary] |
| GS1 | 10840861100634 [Package] Contains: 00840861100637 Package: bag [30 Units] In Commercial Distribution |
| GS1 | 20840861100631 [Package] Contains: 10840861100634 Package: Case [16 Units] In Commercial Distribution |
FDA Product Code
| KDJ | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-10-02 |
Devices Manufactured by Fresenius Medical Care Holdings, Inc.
| 10840861102638 - FX CorAL 60 Dialyzer | 2024-03-04 |
| 10840861102652 - FX CorAL 100 Dialyzer | 2024-03-04 |
| 10840861102669 - FX CorAL 120 Dialyzer | 2024-03-04 |
| 10840861102676 - FX CorAL 600 Dialyzer | 2024-03-04 |
| 10840861102683 - FX CorAL 800 Dialyzer | 2024-03-04 |
| 10840861102690 - FX CorAL 1000 Dialyzer | 2024-03-04 |
| 10840861102409 - CombiSet | 2023-10-27 |
| 10840861102645 - FX CorAL 80 Dialyzer | 2023-10-12 |
Trademark Results [DEL-CLAMP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DEL-CLAMP 74454813 1914732 Live/Registered |
Fresenius USA, Inc. 1993-11-01 |
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