Mini Ghost™ 612538

GUDID 04046964341168

MG123 MINI GHOST BALLOON 3.5 X 4X 80

B BRAUN INTERVENTIONAL SYSTEMS, INC

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 04046964341168
• NIH Device Record Key: 0018f014-6552-4ca3-ba79-512a38188685
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini Ghost™
• Version Model Number: 612538
• Catalog Number: 612538
• 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

• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com

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 *ROOM TEMP AWAY FROM SUNLIGHT
• 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
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964341168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051343

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-03-25
• Device Publish Date: 2016-08-09

On-Brand Devices [Mini Ghost™]

• 04046964346767: MG273 MINI GHOST 2.5MM X8CM X 150CM
• 04046964346750: MG313 MINI GHOST 6MM X4CM X 150CM
• 04046964346736: MG312 MINI GHOST 6MM X3CM X 150CM
• 04046964346712: MG311 MINI GHOST 6MM X2CM X 150CM
• 04046964346699: MG307 MINI GHOST 5.5MM X4CM X 150CM
• 04046964346675: MG306 MINI GHOST 5.5MM X3CM X 150CM
• 04046964346651: MG305 MINI GHOST 5.5MM X2CM X 150CM
• 04046964346637: MG301 MINI GHOST 5MM X4CM X 150CM
• 04046964346620: MG300 MINI GHOST 5MM X3CM X 150CM
• 04046964346606: MG299 MINI GHOST 5MM X2CM X 150CM
• 04046964346583: MG295 MINI GHOST 4.5MM X4CM X 150CM
• 04046964346569: MG294 MINI GHOST 4.5MM X3CM X 150CM
• 04046964346545: MG293 MINI GHOST 4.5MM X2CM X 150CM
• 04046964346521: MG289 MINI GHOST 4MM X4CM X 150CM
• 04046964346507: MG288 MINI GHOST 4MM X3CM X 150CM
• 04046964346484: MG287 MINI GHOST 4MM X2CM X 150CM
• 04046964346460: MG283 MINI GHOST 3.5MM X4CM X 150CM
• 04046964346446: MG282 MINI GHOST 3.5MM X3CM X 150CM
• 04046964346422: MG281 MINI GHOST 3.5MM X2CM X 150CM
• 04046964346408: MG277 MINI GHOST 3MM X4CM X 150CM
• 04046964346385: MG276 MINI GHOST 3MM X3CM X 150CM
• 04046964346361: MG275 MINI GHOST 3MM X2CM X 150CM
• 04046964346347: MG271 MINI GHOST 2.5MM X4CM X 150CM
• 04046964346323: MG270 MINI GHOST 2.5MM X3CM X 150CM
• 04046964346309: MG269 MINI GHOST 2.5MM X2CM X 150CM
• 04046964346286: MG265 MINI GHOST 2MM X4CM X 150CM
• 04046964346262: MG264 MINI GHOST 2MM X3CM X 150CM
• 04046964346248: MG263 MINI GHOST 2MM X2CM X 150CM
• 04046964346224: MG316 MINI GHOST 6MM X10CM X 150CM
• 04046964346200: MG262 MINI GHOST 6MM X10CM X 120CM
• 04046964346187: MG261 MINI GHOST 6MM X 10CM X 80CM
• 04046964346163: MG260 MINI GHOST 6MM X 10CM X 40CM
• 04046964346132: MG315 MINI GHOST 6MM X 8CM X 150CM
• 04046964346118: MG259 MINI GHOST 6MM X 8CM X 120CM
• 04046964346095: MG258 MINI GHOST 6MM X 8CM X 80CM
• 04046964346071: MG257 MINI GHOST 6MM X 8CM X 40CM
• 04046964346064: MG314 MINI GHOST 6MM X 6CM X 150CM
• 04046964346040: MG256 MINI GHOST 6MM X 6CM X 120CM
• 04046964346026: MG255 MINI GHOST 6MM X 6CM X 80CM
• 04046964345999: MG254 MINI GHOST 6MM X 6CM X 40CM
• 04046964345975: MG310 MINI GHOST 5.5MM X 10CM X 150CM
• 04046964345951: MG253 MINI GHOST 5.5MM X 10CM X 120CM
• 04046964345937: MG252 MINI GHOST 5.5MM X 10CM X 80CM
• 04046964345913: MG251 MINI GHOST 5.5MM X 10CM X 40CM
• 04046964345890: MG309 MINI GHOST 5.5MM X 8CM X 150CM
• 04046964345876: MG250 MINI GHOST 5.5MM X 8CM X 120CM
• 04046964345852: MG249 MINI GHOST 5.5MM X 8CM X 80CM
• 04046964345838: MG248 MINI GHOST 5.5MM X 8CM X 40CM
• 04046964345807: MG308 MINI GHOST 5.5MM X 6CM X 150CM
• 04046964345784: MG247 MINI GHOST 5.5MM X 6CM X 120CM