AccessGUDID - DEVICE: Walgreens (00311917203065)

GUDID

Device Identifier (DI) Information

Brand Name: Walgreens
Version or Model: 490530
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WRX490530
Company Name: WALGREEN CO.

Primary DI Number: 00311917203065
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008965063 *Terms of Use

Device Description: Mobility Rollator. Supports up to 350 lbs (159 kg).

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":	Yes
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?
38702	Walking chair, foldable	An all-wheeled mobility aid in the form of a foldable framework that has a built-in seat or sling that supports a disabled or geriatric person in a sitting position while walking. It is constructed of lightweight metal, plastic, rubber and textile materials in the shape of a low centre-of-gravity mobile support structure in which the user walks while seated. The device is foldable and may include forearm supports and a braking mechanism.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKX	Aid, Transfer

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e6a1f3fb-78da-478b-b3cd-2b9dd3420a32
Public Version Date: July 22, 2020
Public Version Number: 1
DI Record Publish Date: July 14, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found 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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-800-925-4733
Email: consumerrelations.pq@walgreens.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES