AccessGUDID - DEVICE: Well at Walgreens (00311917159171)

GUDID

Device Identifier (DI) Information

Brand Name: Well at Walgreens
Version or Model: 277302
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WRX277302V1
Company Name: WALGREEN CO.

Primary DI Number: 00311917159171
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008965063 *Terms of Use

Device Description: Walgreens Foam Ring Cushion

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:	Yes
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?
44361	Foam-filled chair cushion	A foam-filled pad designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair and may contain weight-distribution air cells. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KIC	Cushion, Flotation

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
Length: 18 Inch
Width: 16 Inch
Height: 3 Inch

Device Record Status

Public Device Record Key: bbd613bf-ae41-4bc3-b8cb-5d76515f85f3
Public Version Date: July 31, 2020
Public Version Number: 1
DI Record Publish Date: July 23, 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
10311917159178	6	00311917159171		In Commercial Distribution	case

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