AccessGUDID - DEVICE: Getinge Assure Green Tape 1 IN (00814434020448)

GUDID

Device Identifier (DI) Information

Brand Name: Getinge Assure Green Tape 1 IN
Version or Model: 61301606669
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 61301606669
Company Name: STERITEC PRODUCT MFG. CO., INC.

Primary DI Number: 00814434020448
Issuing Agency: GS1
Commercial Distribution End Date: June 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 622223196 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOJ	Indicator, Physical/Chemical Sterilization Process

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122555	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 38 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 567e5528-54ce-431a-aec6-ca6f1f1fd231
Public Version Date: June 02, 2025
Public Version Number: 7
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10814434020445	36	00814434020448	2025-06-01	Not in Commercial Distribution	Case
20814434020442	9	00814434020448	2025-06-01	Not in Commercial Distribution	Sleeve
30814434020449	4	20814434020442	2025-06-01	Not in Commercial Distribution	Case