J-Wand Advantage

GUDID 30851232007111

Single-use, rigid intubating stylet.

D R BURTON HEALTHCARE, LLC

Artificial airway stylet, single-use
Primary Device ID30851232007111
NIH Device Record Keyc9746ccf-dc53-4543-8986-c93e7a0a5ff3
Commercial Distribution StatusIn Commercial Distribution
Brand NameJ-Wand Advantage
Version Model Number1
Company DUNS080384219
Company NameD R BURTON HEALTHCARE, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2522287038
Emailinquiries@drburtonhpi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110851232007117 [Primary]
GS130851232007111 [Package]
Contains: 10851232007117
Package: CASE [10 Units]
In Commercial Distribution
GS140851232007118 [Package]
Package: CASE [10 Units]
In Commercial Distribution

FDA Product Code

BSRStylet, Tracheal Tube

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-27
Device Publish Date2019-07-03

Devices Manufactured by D R BURTON HEALTHCARE, LLC

10851232007018 - vPEP2023-11-17 This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive exp
10851232007025 - vPEP-HC2023-11-17 This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive exp
10851232007520 - iPEP2023-11-17 This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive exp
10851232007568 - PocketPEP2023-11-17 This is a single patient multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expi
10851232007551 - PocketPEP Advantage2021-07-09 This is a single patient multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expi
30851232007685 - PocketPEP with OxyJET2020-04-20 A handheld oscillating positive expiratory pressure device for secretion clearance with the ability to deliver supplemental oxyg
30851232007722 - PocketPEP Advantage with OxyJET2020-04-20 A handheld oscillating positive expiratory pressure device with the ability to deliver supplemental oxygen when used with compre
30851232007111 - J-Wand Advantage2020-03-27Single-use, rigid intubating stylet.
30851232007111 - J-Wand Advantage2020-03-27 Single-use, rigid intubating stylet.

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