Busse Hospital Disposables 371

GUDID 20849233000937

Procedural Masks

ROBERT BUSSE & CO., INC.

Surgical/medical face mask, single-use
Primary Device ID20849233000937
NIH Device Record Keycb47440b-6e1c-444a-8b32-e2855b4046fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameBusse Hospital Disposables
Version Model Number371
Catalog Number371
Company DUNS002418234
Company NameROBERT BUSSE & CO., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1 (631) 435-4711
Emailmail@busseinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100849233000933 [Primary]
GS110849233000930 [Package]
Contains: 00849233000933
Package: [100 Units]
In Commercial Distribution
GS120849233000937 [Package]
Contains: 10849233000930
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FXXMask, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-06
Device Publish Date2016-09-01

On-Brand Devices [Busse Hospital Disposables]

00849233018174PAIN PACK
00849233018167Sterile Universal Nerve Block Tray
00849233018150Epidural Tray
00849233018143Sterile Nerve Block Tray
00849233018136Central Line Dressing Change Tray
10849233018119Nerve Block Tray #2
10849233018102Umbilical Cord Clamp, Bulk
00849233018051Epidural Tray
10849233018041Sterile Nerve Block Tray
00849233018037Safety Lumbar Puncture Tray w/ 20 Gauge x 3 1/2" Spinal Needle & Manometer
00849233018020Safety Lumbar Puncture Tray with 18 Gauge x 3 1/2" Spinal Needle & Manometer
00849233018013Pediatric Infant Safety Lumbar Puncture Tray w/ 22 g x 21 1/2" spinal Needle
00849233018006Pediatric Infant Safety Lumbar Puncture Tray w/ 21 g x 21 1/2" spinal Needle
00849233017993Caudal Tray
10849233017983Dressing Change Kit
00849233017962Arthrogram Tray
00849233017955Spinal Tray # 1
10849233017938Transforaminal Tray
00849233017924Nerve Block Tray
00849233017900Permanent Catheter Dressing Change CHG Kit
00849233017887Spinal Cord Stimulator
0084923301787018 Gauge Epidural Tray
0084923301786318 Gauge Single Shot Epidural Tray
00849233017849Lumbar Puncture Tray
00849233017832Nerve Block Tray
10849233017815Pain Block Tray
00849233017801Nerve Block Tray
00849233017795Single Shot Epidural Tray
00849233017788Lumbar Tray
00849233017771Female Pellet Insertion Tray
00849233017764Universal Block Tray
00849233017757Basic Pain Tray
00849233017740Nerve Block Tray
00849233017733Single Shot Epidural Tray
10849233017723Arthrogram Tray
00849233017719The 1% Tray
00849233017702The 2% Tray
00849233017696Basic Nerve Block Tray
00849233017689Universal Block Tray
00849233017672Nerve Block Tray
10849233017662Pain Support Lumbar Tray
00849233017658Universal Block Tray
00849233017641Epidural Tray
00849233017627Catheter Access Port Procedure Kit
00849233017610Single Shot Epidural Tray
00849233017603Fenestrated Towel/Drape
00849233017597Myelogram Tray
00849233017573Dr. Bukhalo's Single Shot Epidural Tray - 22 Gauge
00849233017566Nerve Block Tray
00849233017559Sterile Nerve Block Tray

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