Clinical Guard

GUDID 00897429002513

Clinical Guard

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