PENCAN® 560619

GUDID 04046964321306

Spinal Tray

B. BRAUN MEDICAL INC.

Intrathecal anaesthesia set, non-medicated

• Primary Device ID: 04046964321306
• NIH Device Record Key: 2b38cf5b-3f7f-48d7-9498-8833312b9167
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PENCAN®
• Version Model Number: 560619
• Catalog Number: 560619
• Company DUNS: 002397347
• Company Name: B. BRAUN MEDICAL INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964321290 [Unit of Use]
GS1	04046964321306 [Primary]

FDA Product Code

• OFU: Spinal 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 [PENCAN®]

• 04046964941313: P25BKN SPINAL TRAY NRFIT
• 04046964941290: P24BKN 24G PENCAN TRAY W/BUP & DEX NRFIT
• 04046964940996: P2440N 24G X103 PEN NDL W/20G INTR NRFIT
• 04046964558757: GOVP24BK 24G PENCAN TRAY W/BUP & DEXTROS
• 04046964558696: GOVP25BK SPINAL TRAY
• 04046964529191: Pencan® 24 Ga. x 4 in. (100 mm) Tray (Kit)
• 04046964321306: Spinal Tray
• 04046964180903: Pencan® 27 Ga. x 3&fra c12; in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit)
• 04046964180866: Pencan® 24 Ga. x 4 in. (100 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit)
• 04046964180842: Pencan® 24 Ga. x 4 in. (100 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) - Includes D
• 04046964180804: Pencan® 25 Ga. x 3&fra c12; in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) - Saf
• 04046964180743: Pencan® 25 Ga. x 3&fra c12; in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) - Inc
• 04046964180705: Pencan® 25 Ga. x 3&fra c12; in. (90 mm) Tray (Kit)
• 04046964180682: Pencan® 25 Ga. x 3&fra c12; in. (90 mm) Tray (Kit)
• 04046964180606: Pencan® 25 Ga. x 3&fra c12; in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit)
• 04046964181023: Pencan® 25 Ga. x 2 in. (50 mm) Spinal Needle
• 04046964181009: Pencan® 25 Ga. x 1 in. (25 mm) Spinal Needle
• 04046964180989: Pencan® 27 Ga. x 5 in. (127 mm) Spinal Needle
• 04046964180965: Pencan® 25 Ga. x 5 in. (130 mm) Spinal Needle
• 04046964180941: Pencan® 27 Ga. x 3-1/2 in. (90 mm) Spinal Needle
• 04046964180828: Pencan® 22 Ga. x 3-1/2 (90 mm) Spinal Needle
• 04046964180644: Pencan® 25 Ga. x 3-1/2 in. (90 mm) Spinal Needle
• 04046955768295: 25GA X 1 SPINAL NEEDLE NRFIT
• 04046964941030: P25127 PENCAN SPINAL NEEDLE NRFIT
• 04046964941016: P2535N PENCAN SPINAL 25GA NRFIT
• 04046964181047: Pencan® 24 Ga. x 4 in (100 mm) Spinal Needle with 20 Ga. Introducer
• 04046963069568: Pencan® 25 Ga. x 6.1 in. (156 mm) Spinal Needle