DOPPLER MODEL 1058-C W/PPG

GUDID 00816787020052

PARKS MEDICAL ELECTRONICS, INC.

Limb plethysmograph Limb plethysmograph Limb plethysmograph

• Primary Device ID: 00816787020052
• NIH Device Record Key: 313e455f-0474-4ce3-b2b2-e8d171fbc6e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOPPLER MODEL 1058-C W/PPG
• Version Model Number: 1058-C
• Company DUNS: 009041773
• Company Name: PARKS MEDICAL ELECTRONICS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• 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

Customer Support Contacts

• Phone: +1(800)547-6427
• Email: twelker@parksmed.com
• Phone: +1(800)547-6427
• Email: twelker@parksmed.com
• Phone: +1(800)547-6427
• Email: twelker@parksmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816787020052 [Primary]

FDA Product Code

• JOM: PLETHYSMOGRAPH, PHOTOELECTRIC, PNEUMATIC OR HYDRAULIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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• 00816787024357 - 9.1MHz Pencil Probe 7 Foot ODU connector: 2022-05-23
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• 00816787024371 - 9.7MHz Pencil Probe 7 Foot ODU connector: 2022-05-23
• 00816787024302 - 8.1 MHz Pencil Probe 7FT Contoured: 2021-05-24