AccessGUDID - DEVICE: BELT WALKER PEDIATRIC (10) (00733657284690)

GUDID

Device Identifier (DI) Information

Brand Name: BELT WALKER PEDIATRIC (10)
Version or Model: 3123
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2970000595
Company Name: ALIMED, INC.

Primary DI Number: 00733657284690
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056007248 *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":	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?
63227	Movement-resistance gait rehabilitation device	A collection of wearable belts, vest, straps and pulleys designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) with regaining lost motor function for ambulation using movement-resistant attachments to the legs/feet. This is a non-powered device intended to be used in the home.	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: 113c8d3c-a634-4e0c-bbac-3b3d307fc649
Public Version Date: February 19, 2024
Public Version Number: 2
DI Record Publish Date: December 01, 2022

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: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: +1(781)329-2900 ext: 0
Email: customerservice@alimed.com

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

FDA TOOLS & RESOURCES