Sha

GUDID 10822383508334

SHA, Pacifica Elite Neb

Drive Devilbiss Healthcare

Nebulizing system, non-heated

• Primary Device ID: 10822383508334
• NIH Device Record Key: 5a48aacf-6bf0-48a6-8d25-6b39fd87b69c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sha
• Version Model Number: 18071-SHA
• Company DUNS: 867673159
• Company Name: Drive Devilbiss Healthcare
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822383508337 [Primary]
GS1	10822383508334 [Package]; Contains: 00822383508337; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003344

FDA Product Code

• CAF: NEBULIZER (DIRECT PATIENT INTERFACE)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

Devices Manufactured by Drive Devilbiss Healthcare

• 00822383004242 - Drive: 2024-10-21 Product Description Wheeled Commode with Footrests, 1/CV
• 00311917192352 - Walgreens: 2024-10-07 Personal Care Aids to Daily Living Product Description Unisex Urinal, 6/CS
• 50822383116605 - DRIVEMEDICAL: 2024-10-03 Transport/WheelchairTransport Chairs Product Description: Tran Sport Chair,FlipBack-RemArms,1/cs
• 00822383003207 - Drive: 2024-10-01 Product Description LA-SlvSprt2,16in SlvrVnDetDsk,SwgFt,1/cs
• 00822383003214 - Drive: 2024-10-01 Product Description LA-SlvSprt2,18in SlvrVnDetDsk,SwgFt,1/cs
• 00822383001708 - Drive: 2024-09-30 Product Description PriceSmart Scout 4-Whl Sctr, Rd/Bl, 1/ea
• 00822383003009 - DRIVE: 2024-09-30 Transport chairs/Wheelchairs Wheelchairs K4 Product Description CruiserX4, 18" DetDsk Arm, ElvLg, 1/ea
• 00822383004075 - Drive: 2024-04-18 Product Description CMS Fingertip Pulse Oximeter 1/ea