J-Wand

GUDID 10851232007070

Single Use Semi-rigid Intubating Stylet.

D R BURTON HEALTHCARE, LLC

Artificial airway stylet, single-use

• Primary Device ID: 10851232007070
• NIH Device Record Key: c1f14397-d517-4f11-8bca-a7aaef275c15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: J-Wand
• Version Model Number: 1
• Company DUNS: 080384219
• Company Name: D R BURTON HEALTHCARE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: 2522287038
• Email: inquiries@drburtonhpi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10851232007070 [Primary]
GS1	30851232007074 [Package]; Package: CASE [10 Units]; In Commercial Distribution

FDA Product Code

• BSR: Stylet, Tracheal Tube

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-09
• Device Publish Date: 2019-05-01

Devices Manufactured by D R BURTON HEALTHCARE, LLC

• 10851232007018 - vPEP: 2023-11-17 This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive exp
• 10851232007025 - vPEP-HC: 2023-11-17 This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive exp
• 10851232007520 - iPEP: 2023-11-17 This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive exp
• 10851232007568 - PocketPEP: 2023-11-17 This is a single patient multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expi
• 10851232007551 - PocketPEP Advantage: 2021-07-09 This is a single patient multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expi
• 30851232007685 - PocketPEP with OxyJET: 2020-04-20 A handheld oscillating positive expiratory pressure device for secretion clearance with the ability to deliver supplemental oxyg
• 30851232007722 - PocketPEP Advantage with OxyJET: 2020-04-20 A handheld oscillating positive expiratory pressure device with the ability to deliver supplemental oxygen when used with compre
• 30851232007111 - J-Wand Advantage: 2020-03-27 Single-use, rigid intubating stylet.