Avalon Fetal & Maternal Patch

Basic Information

• Brand Name: Avalon Fetal & Maternal Patch
• Primary DI: 20884838059324
• Version / Model: Avalon CL Fetal & Maternal Patch
• Catalog Number: 989803196341
• Company Name: Philips Medical Systems Hsg
• Labeler DUNS: 790605856
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-05-25
• Public Version: 5
• Public Version Date: 2023-01-11
• Public Version Status: Update
• Public Device Record Key: f21853bf-14bf-4e5c-9f8c-969cfc091307

Device Description

Avalon CL Fetal & Maternal Patch to be used with Avalon CL Fetal & Maternal Pod 866488. Patch is Single Patient Use and consists of a cradle and 5 electrodes. 1 Box= 10 patches.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HFM	Monitor, uterine contraction, external (for use in clinic)	Obstetrics/Gynecology	884.2720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37796	Foetal/maternal prenatal monitor	An electrically-powered device designed for continuous monitoring of foetal heart activity and maternal uterine contractions during the prenatal (commonly perinatal) period; it may monitor additional maternal parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse oximetry (SpO2)]. Also known as a cardiotocograph, uterine contractions are acquired using a tocodynamometer (pressure transducer) strapped onto the mother's abdomen, while foetal heart rate is typically measured with a dedicated ultrasound transducer. The results may be displayed via print-out or electronically; telemetry features may also be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20884838059324	GS1
Unit of Use	00884838059320	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity