JOHN BUNN

GUDID M368JB01120672

NEB-U-TYKE SPEEDSTER

GF HEALTH PRODUCTS, INC.

Benchtop nebulizer, non-heated

• Primary Device ID: M368JB01120672
• NIH Device Record Key: 21126d44-a033-4eed-a5ae-082cb3e9017e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JOHN BUNN
• Version Model Number: JB0112-067
• Company DUNS: 132016168
• Company Name: GF HEALTH PRODUCTS, 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M368JB01120671 [Primary]
HIBCC	M368JB01120672 [Package]; Contains: M368JB01120671; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052811

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: 5
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-08-31

On-Brand Devices [JOHN BUNN]

• M368020202: Finger Pulse Oximeter
• M368JB01120902: Neb-u-Lite EV2 Nebulizer
• M368JB01121112: Neb-u-LiteLX3 Nebulite Compressor
• M368325581: Jackson Trachea Plug
• M368325561: Jackson Trachea Plug
• M368325551: Jackson Trachea Plug
• M368325541: Jackson Trachea Plug
• M358325571: Jackson Trachea Plug
• M368GF642320: TUBING O2 SURE-FLO 25', 25/CS
• M368GF640410: MASK 02W/7ft TUBING ADLT 50/CS
• M368GF332420: CANNULA NASAL W/ 25' TUBING
• M368GF332390: CANNULA NASAL W/7' TUBING
• M368S1311: ASPIRATOR W/ DLX STAND
• M368JB01500861: REGULATOR H CGA540 0-15 W/GAGE
• M368JB01500831: REGULATOR 0-8 W/GAUGE DISS
• M368JB01500821: REGULATOR 0-15 W/GAUGE YOKE ST
• M368JB01500811: REGULATOR 0-8 W/GAUGE YOKE STY
• M368JB020171: OxyRead Finger Pulse Oximeter
• M368JB020081: DigiOx Finger Pulse Oximeter
• M368JB020071: DigiOx Finger Pulse Oximeter
• M368JB01121642: NEB-U-TYKE RR TRAIN
• M368JB01121101: Neb-u-Lite LX Nebulizer Compressor
• M368JB01120712: Neb-u-Tyke Nebulizer Compressor
• M368JB01120702: NEB-U-TYKE NEB-A-DOODLE
• M368JB01120672: NEB-U-TYKE SPEEDSTER
• M368JB01120622: NEB-U-TYKE IC Penguin
• M368JB01120612: NEB-U-LITE EV
• M368GF640952: Nebulizer Set, Pediatric
• M368GF614002: Complete Nebulizer Set
• M368GF613992: Complete Nebulizer Set
• M36857102: Lumineb II Nebulizer Compressor
• M368GF813702: Mouthpiece, 22 mm