Jelco

Basic Information

• Brand Name: Jelco
• Primary DI: 05019315057918
• Version / Model: HC04
• Company Name: Smiths Medical ASD, Inc.
• Labeler DUNS: 082005361
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-03
• Public Version: 4
• Public Version Date: 2020-03-27
• Public Version Status: Update
• Public Device Record Key: df37b9bd-1c22-47a7-8abf-c66a27fe2f41

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FYH	SPLINT, EXTREMITY, NONINFLATABLE, EXTERNAL, STERILE	General, Plastic Surgery	878.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12097	Infant limb immobilizer, reusable	A non-rigid device, usually made of a fabric and/or plastic materials, used to temporarily render parts of an infant's body immovable, e.g., the arms and/or feet while the patient undergoes therapeutic or diagnostic interventions. It will typically be used to prevent the patient from interrupting an intravenous (IV) infusion, pulling out a catheter, or interfering with wound care. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	35019315057919	GS1	Carton	20	In Commercial Distribution
Primary	05019315057918	GS1