Z-MED™ 610486
GUDID 04046964329319
PDZ336 Z-MED 15X4X100
B BRAUN INTERVENTIONAL SYSTEMS, INC
Cardiac valvuloplasty catheter| Primary Device ID | 04046964329319 |
| NIH Device Record Key | a38c090d-b3cf-44f7-83d6-fc886ccf4dfe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Z-MED™ |
| Version Model Number | 610486 |
| Catalog Number | 610486 |
| 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 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964329319 [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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