DOPPLEX

Basic Information

• Brand Name: DOPPLEX
• Primary DI: 05051968013941
• Version / Model: ACC56
• Catalog Number: ACC56
• Company Name: HUNTLEIGH HEALTHCARE LIMITED
• Labeler DUNS: 217207083
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: ce604f19-5da2-4a46-a3c6-7918517ebba0

Device Description

BOX,PPG ADHESIVE PAD - 500 OFF

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Cardiovascular	870.2780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16866	Dressing-fixation skin adhesive tape, non-silicone	A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051968013941	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity