Encompass

Basic Information

• Brand Name: Encompass
• Primary DI: 00609953090252
• Version / Model: 45772-608
• Company Name: Encompass Group, L.L.C.
• Labeler DUNS: 121788819
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-02
• Public Version: 2
• Public Version Date: 2023-05-05
• Public Version Status: Update
• Public Device Record Key: a4838275-58a1-46b9-a0a9-697e2b71cc5c

Device Description

GOWN IV PEDIATRIC STARGAZING SIZE 6-8 STARGAZING 100% P

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• 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
FME	Gown, Examination	General Hospital	880.6265	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11905	Patient gown, reusable	A garment made of natural and/or synthetic materials (e.g., cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and is closed by ties at the back/side of the garment. This is a reusable garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50609953090257	GS1	CA	60	In Commercial Distribution
Primary	00609953090252	GS1

Customer Contacts

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