BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Getinge Assured Control Card

DI: 00814434021186 · Model: 61301606815 · STERITEC PRODUCT MFG. CO., INC.

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

1

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Basic Information

Brand Name: Getinge Assured Control Card
Primary DI: 00814434021186
Version / Model: 61301606815
Catalog Number: 61301606815
Company Name: STERITEC PRODUCT MFG. CO., INC.
Labeler DUNS: 622223196
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2019-06-10
Public Version: 3
Public Version Date: 2025-02-21
Public Version Status: Update
Public Device Record Key: e6efcb1f-4025-44a3-9163-11380f89ecab

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: 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	20814434021180	GS1	Case	16	In Commercial Distribution
Package	10814434021183	GS1	Box	250	In Commercial Distribution
Primary	00814434021186	GS1

Storage Conditions

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