BIB® 614424

GUDID 04046964900013

BB010 BIB Catheter 16 3 9F

B BRAUN INTERVENTIONAL SYSTEMS, INC

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 04046964900013
• NIH Device Record Key: e4af51f6-3fd4-4c30-9bfd-12f7fabeb14c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIB®
• Version Model Number: 614424
• Catalog Number: 614424
• 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: false
• 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

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964900013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050857

FDA Product Code

• NVM: Catheter, angioplasty, peripheral, transluminal, dual-balloon

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: 2020-04-07
• Device Publish Date: 2016-09-23

On-Brand Devices [BIB®]

• 04046964901355: BB058 BIB Catheter 15 4.5 9F
• 04046964900334: BB050 BIB Catheter 10 5.5 8F
• 04046964900327: BB049 BIB Catheter 10 5 8F
• 04046964900310: BB021 BIB Catheter 24 5.5 11F
• 04046964900303: BB036 BIB Catheter 24 5 11F
• 04046964900297: BB018 BIB Catheter 24 4.5 11F
• 04046964900280: BB015 BIB Catheter 24 4 11F
• 04046964900273: BB067 BIB Catheter 24 3.5 11F
• 04046964900266: BB012 BIB Catheter 24 3 11F
• 04046964900259: BB066 BIB Catheter 22 5.5 11F
• 04046964900242: BB065 BIB Catheter 22 5 11F
• 04046964900235: BB064 BIB Catheter 22 4.5 11F
• 04046964900228: BB063 BIB Catheter 22 4 11F
• 04046964900211: BB062 BIB Catheter 22 3.5 11F
• 04046964900204: BB061 BIB Catheter 22 3 11F
• 04046964900198: BB020 BIB Catheter 20 5.5 10F
• 04046964900181: BB032 BIB Catheter 20 5 10F
• 04046964900174: BB017 BIB Catheter 20 4.5 10F
• 04046964900167: BB014 BIB Catheter 20 4 10F
• 04046964900150: BB042 BIB Catheter 20 3.5 10F
• 04046964900143: BB011 BIB Catheter 20 3 10F
• 04046964900136: BB031 BIB Catheter 18 5.5 10F
• 04046964900129: BB030 BIB Catheter 18 5 10F
• 04046964900112: BB029 BIB Catheter 18 4.5 10F
• 04046964900105: BB041 BIB Catheter 18 4 10F
• 04046964900099: BB027 BIB Catheter 18 3.5 10F
• 04046964900082: BB040 BIB Catheter 18 3 10F
• 04046964900075: BB024 BIB Catheter 18 2.5 10F
• 04046964900068: BB019 BIB Catheter 16 5.5 9F
• 04046964900051: BB028 BIB Catheter 16 5 9F
• 04046964900044: BB016 BIB Catheter 16 4.5 9F
• 04046964900037: BB013 BIB Catheter 16 4 9F
• 04046964900020: BB026 BIB Catheter 16 3.5 9F
• 04046964900013: BB010 BIB Catheter 16 3 9F
• 04046964900006: BB023 BIB Catheter 16 2.5 9F
• 04046964899997: BB060 BIB Catheter 15 5.5 9F
• 04046964899980: BB059 BIB Catheter 15 5 9F
• 04046964899973: BB057 BIB Catheter 15 4 9F
• 04046964899966: BB056 BIB Catheter 15 3.5 9F
• 04046964899959: BB055 BIB Catheter 15 3 9F
• 04046964899942: BB054 BIB Catheter 15 2.5 9F
• 04046964899935: BB053 BIB Catheter 14 5.5 8F
• 04046964899928: BB039 BIB Catheter 14 5 8F
• 04046964899911: BB035 BIB Catheter 14 4.5 8F
• 04046964899904: BB038 BIB Catheter 14 4 8F
• 04046964899898: BB025 BIB Catheter 14 3.5 8F
• 04046964899881: BB052 BIB Catheter 14 3 8F
• 04046964899874: BB022 BIB Catheter 14 2.5 8F
• 04046964899867: BB051 BIB Catheter 12 5.5 8F
• 04046964899850: BB034 BIB Catheter 12 5 8F