Z-MED™ 610459
GUDID 04046964328800
PDZ309 SPECIAL Z-MED 16X3X85
B BRAUN INTERVENTIONAL SYSTEMS, INC
Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter| Primary Device ID | 04046964328800 |
| NIH Device Record Key | b6afbc82-1f40-4e5f-adb2-645bb0e06653 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Z-MED™ |
| Version Model Number | 610459 |
| Catalog Number | 610459 |
| Company DUNS | 784259751 |
| Company Name | B BRAUN INTERVENTIONAL SYSTEMS, 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 | 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964328800 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K122012
FDA Product Code
| LIT | Catheter, angioplasty, peripheral, transluminal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-11-02 |
| Device Publish Date | 2016-08-09 |
On-Brand Devices [Z-MED™]
| 04046964337918 | SO022 SPECIAL Z-MED 2X2X90 |
| 04046964337956 | SO025 SPECIAL Z-MED 3X4X90 |
| 04046964336409 | SO096 SPECIAL Z-MED 28X8X100 |
| 04046964335044 | PDZ373 SPECIAL Z-MED 18X3X100 |
| 04046964329500 | PDZ361 SPECIAL Z-MED 15X5X100 |
| 04046964329432 | PDZ344 SPECIAL Z-MED 6X3X100 |
| 04046964329074 | PDZ324 SPECIAL Z-MED 5X2X100 |
| 04046964329050 | PDZ323 SPECIAL Z-MED 4X2X100 |
| 04046964328909 | PDZ314 SPECIAL Z-MED 9X2X85 |
| 04046964328725 | PDZ305 SPECIAL Z-MED 10X2X85 |
| 04046964328701 | PDZ304 SPECIAL Z-MED 8X2X85 |
| 04046964328688 | PDZ303 SPECIAL Z-MED 7X2X85 |
| 04046964328664 | PDZ302 SPECIAL Z-MED 6X2X85 |
| 04046964328640 | PDZ301 SPECIAL Z-MED 5X2X85 |
| 04046964328626 | PDZ300 SPECIAL Z-MED 4X2X85 |
| 04046964555091 | SO067 Z-MED 18X2X120 |
| 04046964338724 | SO064 Z-MED 28X4X75 |
| 04046964338700 | SO063 Z-MED 26X4X75 |
| 04046964338687 | SO062 Z-MED 30X4X75 |
| 04046964338663 | SO061 Z-MED 26X2X100 |
| 04046964338649 | SO060 Z-MED 26X4X100 |
| 04046964338625 | SO059 Z-MED 24X4X100 |
| 04046964338618 | SO058 Z-MED 23X3X120 |
| 04046964338588 | SO057 Z-MED 25X3X120 |
| 04046964338540 | SO055 Z-MED 30X4X120 |
| 04046964338526 | SO054 Z-MED 30X2X120 |
| 04046964338502 | SO053 Z-MED 28X2X120 |
| 04046964338489 | SO052 Z-MED 23X2X120 |
| 04046964338465 | SO051 Z-MED 30X3X120 |
| 04046964338441 | SO050 Z-MED 28X3X120 |
| 04046964338427 | SO049 Z-MED 22X3X120 |
| 04046964338403 | SO048 Z-MED 20X3X120 |
| 04046964338380 | SO047 Z-MED 23X4X120 |
| 04046964338366 | SO046 Z-MED 28X4X120 |
| 04046964338304 | SO043 Z-MED 28X2X85 |
| 04046964338267 | SO041 Z-MED 30X2X85 |
| 04046964337987 | SO027 Z-MED 28X3X85 |
| 04046964336386 | SO094 Z-MED 14X2X85 |
| 04046964336225 | SO092 Z-MED 33X2X75 |
| 04046964336201 | SO091 Z-MED 26X2X85 |
| 04046964336171 | SO090 Z-MED 23X2X85 |
| 04046964336157 | SO089 Z-MED 24X3X100 |
| 04046964336133 | SO088 Z-MED 28X6X100 |
| 04046964336119 | SO087 Z-MED 26X6X100 |
| 04046964336096 | SO085 Z-MED 26X3X75 |
| 04046964336072 | SO084 Z-MED 24X2X75 |
| 04046964336065 | SO083 Z-MED 30X8X100 |
| 04046964336041 | SO082 Z-MED 25X8X100 |
| 04046964336003 | SO080 Z-MED 20X8X100 |
| 04046964335952 | SO078 Z-MED 40X6X100 |
Trademark Results [Z-MED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 Z-MED 85718915 4511596 Live/Registered |
R & F, INC. 2012-09-01 |
 Z-MED 75281663 not registered Dead/Abandoned |
NuMED, INC. 1997-04-24 |
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