AccessGUDID - DEVICE: Rite-Aid Sterile Saline Wound Wash (00011822681537)

GUDID

Device Identifier (DI) Information

Brand Name: Rite-Aid Sterile Saline Wound Wash
Version or Model: 98-50740-200-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RITE AID CORPORATION

Primary DI Number: 00011822681537
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 014578892 *Terms of Use

Device Description: Sterile Saline Wound Wash

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
62389	Wound irrigation cannula	A rigid or semi-rigid tube intended to be connected to a parent device (e.g., syringe) to channel irrigation fluids (e.g., saline solution) to a skin or surgical wound for washing and removing debris; it is not intended for aspiration of fluids. This is a single-use device intended to be used in a sterile condition.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Weight: 211 Gram

Device Record Status

Public Device Record Key: d613abf8-9a60-41aa-99a3-784efe55af7f
Public Version Date: June 22, 2020
Public Version Number: 1
DI Record Publish Date: June 13, 2020