AccessGUDID - DEVICE: Medline (10080196139132)

GUDID

Device Identifier (DI) Information

Brand Name: Medline
Version or Model: MDS88OPASTP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MDS88OPASTP
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10080196139132
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: OPA DISINFECTANT TEST STRIP

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?
46945	Ortho-phthalaldehyde (OPA) device disinfectant test strip	A sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of ortho-phthalaldehyde (OPA) in a device disinfectant solution after preparation to ensure disinfectant properties. It is used to prevent diluting the disinfectant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JOJ	Indicator, physical/chemical sterilization process

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 65c94737-ad88-407b-9c3b-604b884f5c81
Public Version Date: February 06, 2023
Public Version Number: 1
DI Record Publish Date: January 27, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
40080196139133	2	10080196139132		In Commercial Distribution	CASE

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 20080196139139 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-5463
Email: service@medline.com

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