Tempo

Basic Information

• Brand Name: Tempo
• Primary DI: 00891153001187
• Version / Model: 8010
• Company Name: Hemasource, Inc.
• Labeler DUNS: 009046405
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 2
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: aeefb825-6457-4734-9091-579d6d2a7603

Device Description

Tempo Alcohol Prep Pads (Sterile)

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: 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKB	Pad, Alcohol, Device Disinfectant	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
17988	Antiseptic skin towelette	A device that is pre-soaked with an antiseptic and intended to inhibit the growth of microorganisms on the skin; it may also include an anaesthetic to alleviate pain. It is typically designed as a small, absorbent, sterile cloth, usually made of cotton, that is pre-treated and sealed in an individual package. It is used in the hospital environment, in the home, or carried for first aid to prevent infection and provide temporary pain and itching relief associated with minor cuts, scrapes, or burns. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10891153001184	GS1	Case	20	In Commercial Distribution
Primary	00891153001187	GS1