SPRAY / PUMP

Basic Information

• Brand Name: SPRAY / PUMP
• Primary DI: 00860009716124
• Version / Model: 0651, 0681, 0671, 0695, 0661, 0641, 0631
• Company Name: Jhk, Inc.
• Labeler DUNS: 867236309
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2023-07-28
• Public Version: 1
• Public Version Date: 2023-08-07
• Public Version Status: New
• Public Device Record Key: d440353d-300d-4a1f-bafb-f4d0a9f0d207

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IFI	SPRAYS, SYNTHETIC, SMEAR	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16529	Medication spray bottle	An empty, flexible squeeze-container with a spray nozzle used to deliver medication in an atomized form, e.g., nasal spray. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00860009716155	GS1
Primary	00860009716124	GS1