Busse Hospital Disposables 371

GUDID 20849233000937

Procedural Masks

ROBERT BUSSE & CO., INC.

Surgical/medical face mask, single-use

• Primary Device ID: 20849233000937
• NIH Device Record Key: cb47440b-6e1c-444a-8b32-e2855b4046fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Busse Hospital Disposables
• Version Model Number: 371
• Catalog Number: 371
• Company DUNS: 002418234
• Company Name: ROBERT BUSSE & CO., INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1 (631) 435-4711
• Email: mail@busseinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849233000933 [Primary]
GS1	10849233000930 [Package]; Contains: 00849233000933; Package: [100 Units]; In Commercial Distribution
GS1	20849233000937 [Package]; Contains: 10849233000930; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940720

FDA Product Code

• FXX: Mask, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-01

On-Brand Devices [Busse Hospital Disposables]

• 00849233018174: PAIN PACK
• 00849233018167: Sterile Universal Nerve Block Tray
• 00849233018150: Epidural Tray
• 00849233018143: Sterile Nerve Block Tray
• 00849233018136: Central Line Dressing Change Tray
• 10849233018119: Nerve Block Tray #2
• 10849233018102: Umbilical Cord Clamp, Bulk
• 00849233018051: Epidural Tray
• 10849233018041: Sterile Nerve Block Tray
• 00849233018037: Safety Lumbar Puncture Tray w/ 20 Gauge x 3 1/2" Spinal Needle & Manometer
• 00849233018020: Safety Lumbar Puncture Tray with 18 Gauge x 3 1/2" Spinal Needle & Manometer
• 00849233018013: Pediatric Infant Safety Lumbar Puncture Tray w/ 22 g x 21 1/2" spinal Needle
• 00849233018006: Pediatric Infant Safety Lumbar Puncture Tray w/ 21 g x 21 1/2" spinal Needle
• 00849233017993: Caudal Tray
• 10849233017983: Dressing Change Kit
• 00849233017962: Arthrogram Tray
• 00849233017955: Spinal Tray # 1
• 10849233017938: Transforaminal Tray
• 00849233017924: Nerve Block Tray
• 00849233017900: Permanent Catheter Dressing Change CHG Kit
• 00849233017887: Spinal Cord Stimulator
• 00849233017870: 18 Gauge Epidural Tray
• 00849233017863: 18 Gauge Single Shot Epidural Tray
• 00849233017849: Lumbar Puncture Tray
• 00849233017832: Nerve Block Tray
• 10849233017815: Pain Block Tray
• 00849233017801: Nerve Block Tray
• 00849233017795: Single Shot Epidural Tray
• 00849233017788: Lumbar Tray
• 00849233017771: Female Pellet Insertion Tray
• 00849233017764: Universal Block Tray
• 00849233017757: Basic Pain Tray
• 00849233017740: Nerve Block Tray
• 00849233017733: Single Shot Epidural Tray
• 10849233017723: Arthrogram Tray
• 00849233017719: The 1% Tray
• 00849233017702: The 2% Tray
• 00849233017696: Basic Nerve Block Tray
• 00849233017689: Universal Block Tray
• 00849233017672: Nerve Block Tray
• 10849233017662: Pain Support Lumbar Tray
• 00849233017658: Universal Block Tray
• 00849233017641: Epidural Tray
• 00849233017627: Catheter Access Port Procedure Kit
• 00849233017610: Single Shot Epidural Tray
• 00849233017603: Fenestrated Towel/Drape
• 00849233017597: Myelogram Tray
• 00849233017573: Dr. Bukhalo's Single Shot Epidural Tray - 22 Gauge
• 00849233017566: Nerve Block Tray
• 00849233017559: Sterile Nerve Block Tray