Clinical Guard

GUDID 00897429002513

Clinical Guard

Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe

• Primary Device ID: 00897429002513
• NIH Device Record Key: d4b5af30-5fc9-4c32-b1e6-5313549f6f96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clinical Guard
• Version Model Number: Sonoline B
• Company DUNS: 827033924
• Company Name: Clinical Guard
• 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: true
• 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	00897429002513 [Primary]
GS1	10897429002510 [Package]; Package: [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082480

FDA Product Code

• KNG: Monitor, Ultrasonic, Fetal

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: 2022-11-28
• Device Publish Date: 2017-03-30

On-Brand Devices [Clinical Guard]

• 10897429002978: CMS50F
• 20897429002524: CMS 50DL
• 00897429002476: Aero2
• 20897429002463: CMS500S
• 10897429002237: CMS50E
• 00897429002766: Ovulation Urine Test Strip Pack of 50
• 10897429002701: LH40 and HCG 10 Combo
• 00897429002513: Sonoline B