Strapette™

Basic Information

• Brand Name: Strapette™
• Primary DI: 10889483228654
• Version / Model: CP-4404
• Catalog Number: CP-4404
• Company Name: SUNMED, LLC
• Labeler DUNS: 069009268
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-15
• Public Version: 2
• Public Version Date: 2026-03-03
• Public Version Status: Update
• Public Device Record Key: 3f18393f-6030-4160-896c-1a1f7c16f709

Device Description

Neonatal Strapette™ with Large Tube Tackles

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: Yes
• 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
JAY	Support, Breathing Tube	Anesthesiology	868.5280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64491	Medical/surgical interventional tube/cable securement strap	A strip of material in the form of tape/strap intended to be used to secure interventional patient tubes/cables to drapes or device covers in surgical/medical settings; it is not intended to attach to the patient and has no additional intended uses. It may be comprised of, e.g., an adhesive on one side to allow attachment to a drape/cover and Velcro on the other side for securing tubing/cables. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10889483228654	GS1
Previous	00709078013072	GS1
Package	20889483228651	GS1	Box	40	In Commercial Distribution

Customer Contacts

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