MedicaPure
GUDID 10817411020339
Liquid Acid Concentrate
DIMESOL USA, LLC
Haemodialysis concentrate| Primary Device ID | 10817411020339 |
| NIH Device Record Key | 230f6271-85cb-47b4-9686-e4684c0bd4f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MedicaPure |
| Version Model Number | AC-100 |
| Company DUNS | 069723499 |
| Company Name | DIMESOL USA, LLC |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817411020332 [Primary] |
| GS1 | 10817411020339 [Package] Contains: 00817411020332 Package: [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K901471
FDA Product Code
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) |
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 | 2018-08-27 |
| Device Publish Date | 2018-07-25 |
On-Brand Devices [MedicaPure]
| 10817411021039 | Liquid Acid Concentrate |
| 10817411021015 | Liquid Acid Concentrate |
| 10817411020490 | Liquid Acid Concentrate |
| 10817411020438 | Liquid Acid Concentrate |
| 10817411020339 | Liquid Acid Concentrate |
| 10817411020162 | Liquid Acid Concentrate |
| 00817411020110 | Liquid Acid Concentrate |
| 00817411020103 | Liquid Acid Concentrate |
| 10817411020087 | Liquid Acid Concentrate |
| 00817411020073 | Liquid Acid Concentrate |
| 10817411020063 | Liquid Acid Concentrate |
| 00817411020059 | Liquid Acid Concentrate |
| 00817411020042 | Liquid Acid Concentrate |
Trademark Results [MedicaPure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEDICAPURE 97440239 not registered Live/Pending |
NIPRO CORPORATION 2022-06-02 |
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