Primary Device ID | 04953170055546 |
NIH Device Record Key | bd0ed7f8-7976-4a7c-b8bd-9280c2b739fe |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Balloon2 |
Version Model Number | MH-525 |
Company DUNS | 711789789 |
Company Name | OLYMPUS MEDICAL SYSTEMS CORP. |
Device Count | 20 |
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 | false |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)401-1086 |
xx@xx.xx | |
Phone | +1(800)401-1086 |
xx@xx.xx | |
Phone | +1(800)401-1086 |
xx@xx.xx | |
Phone | +1(800)401-1086 |
xx@xx.xx | |
Phone | +1(800)401-1086 |
xx@xx.xx | |
Phone | +1(800)401-1086 |
xx@xx.xx | |
Phone | +1(800)401-1086 |
xx@xx.xx | |
Phone | +1(800)401-1086 |
xx@xx.xx | |
Phone | +1(800)401-1086 |
xx@xx.xx | |
Phone | +1(800)401-1086 |
xx@xx.xx | |
Phone | +1(800)401-1086 |
xx@xx.xx | |
Phone | +1(800)401-1086 |
xx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04953170055546 [Primary] |
GS1 | 84953170055542 [Unit of Use] |
ITX | Transducer, ultrasonic, diagnostic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[04953170055546]
Ethylene Oxide
[04953170055546]
Ethylene Oxide
[04953170055546]
Ethylene Oxide
[04953170055546]
Ethylene Oxide
[04953170055546]
Ethylene Oxide
[04953170055546]
Ethylene Oxide
[04953170055546]
Ethylene Oxide
[04953170055546]
Ethylene Oxide
[04953170055546]
Ethylene Oxide
[04953170055546]
Ethylene Oxide
[04953170055546]
Ethylene Oxide
[04953170055546]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-10-12 |
04953170355745 | MH-525 |
04953170355738 | MH-304 |
04953170355721 | MH-303 |
04953170055546 | MH-525 |
04953170053870 | MH-303 |