Combined Spinal & Epidural 333197

GUDID 04046964179327

PERIFIX® 17 Ga. x 3&fr ac12; in. Tuohy, PENCAN® 27 Ga. x 5 in. Pencil-Point Spinal Needle, PERIFIX® FX 19 Ga. Springwound Ope n Tip,5 mL Glass Luer Slip LOR Tray (Kit)

B. BRAUN MEDICAL INC.

Epidural/intrathecal anaesthesia set, non-medicated

• Primary Device ID: 04046964179327
• NIH Device Record Key: f78fa7b0-400a-4c2d-b8ea-d88675bed0ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Combined Spinal & Epidural
• Version Model Number: 333197
• Catalog Number: 333197
• Company DUNS: 002397347
• Company Name: B. BRAUN MEDICAL INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• 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(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com

Device Dimensions

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Operating and Storage Conditions

• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964179310 [Unit of Use]
GS1	04046964179327 [Primary]

FDA Product Code

• OFT: Spinal epidural anesthesia kit

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: 2020-03-03
• Device Publish Date: 2016-09-23

On-Brand Devices [Combined Spinal & Epidural]

• 04046964940675: NES1827N SPINAL/EPIDURAL SET NRFIT
• 04046964940651: NES1725N SPINAL/EPIDURAL SET NRFIT
• 04046964940637: ES1827KN SPINAL/EPIDURAL TRAY NRFIT
• 04046964940613: ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT
• 04046964306174: Combined Spinal/Epidural Tray
• 04046964179327: PERIFIX® 17 Ga. x 3&fr ac12; in. Tuohy, PENCAN® 27 Ga. x 5 in. Pencil-Point Spinal Needle, PER
• 04046955901197: Combined Spinal/Epidural Tray