Fisher & Paykel Healthcare

Basic Information

• Brand Name: Fisher & Paykel Healthcare
• Primary DI: 09420012433169
• Version / Model: NC100-10
• Catalog Number: NC100-10/25/SK
• Company Name: FISHER & PAYKEL HEALTHCARE LIMITED
• Labeler DUNS: 590153276
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-06
• Public Version: 1
• Public Version Date: 2023-07-14
• Public Version Status: New
• Public Device Record Key: f470645a-aaba-4418-b627-465682587ca2

Device Description

NEOWRAP PE OCCLUSIVE WRAP

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KME	Bedding, Disposable, Medical	General Hospital	880.6060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10417	Infant blanket, reusable	A piece of fabric material intended to be used to wrap newborns/infants to retain their body heat. Commonly known as a baby blanket, it is available in a variety of fabrics (e.g., wool, cotton, or synthetic materials) and textures (e.g., cellular or smooth). This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09420012433169	GS1
Package	09420012418081	GS1	BOX	10	In Commercial Distribution
Package	09420012418319	GS1	BOX	25	In Commercial Distribution
Package	09420012418258	GS1	BOX	2	In Commercial Distribution

Customer Contacts

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