BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

CARDINAL HEALTH

DI: 10885380120176 · Model: T40311LF · Cardinal Health 200, LLC

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: CARDINAL HEALTH
Primary DI: 10885380120176
Version / Model: T40311LF
Catalog Number: T40311LF
Company Name: Cardinal Health 200, LLC
Labeler DUNS: 961027315
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-10-04
Public Version: 8
Public Version Date: 2025-02-21
Public Version Status: Update
Public Device Record Key: 73f2fe1b-4279-48ac-b91e-fbefdce7d013
Distribution End Date: 2023-10-31

Device Description

Indicator Tape 1 in. x 60 yd.

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): Yes
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: Yes
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
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
JOJ	Indicator, physical/chemical sterilization process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35362	Chemical/physical sterilization process indicator	A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885380120174	GS1	CASE	36	Not in Commercial Distribution	2023-10-31
Primary	10885380120176	GS1

Premarket Submissions

Submission Number	Supplement Number
K122555	000

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 10 – 38 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 10 – 70 Percent (%) Relative Humidity