AccessGUDID - DEVICE: Smart Rollboard (00628176153087)

GUDID

Device Identifier (DI) Information

Brand Name: Smart Rollboard
Version or Model: 4010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Samarit Medical Industries Inc

Primary DI Number: 00628176153087
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 247963056 *Terms of Use

Device Description: Disposable Cover Large

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
37162	Patient transfer sliding board	A manual device used by healthcare professionals to assist in the physical movement and transfer of a person/patient (e.g., a hospitalized, a person with a disability, or a geriatric) from one position to another. The device typically has no lifting capabilities and utilizes sliding techniques to move the person. It is typically designed to transfer a person sideways from, e.g., a bed to a chair, or a bed to an operating table, or an operating table to a bed. It may be constructed as a solid sliding board with a low-friction surface, or a roller board (roller system in a framework).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMR	Device, Transfer, Patient, Manual

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: 6d311c5e-4d51-4a30-a1fa-7c33e23086a5
Public Version Date: November 04, 2022
Public Version Number: 1
DI Record Publish Date: October 27, 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: No
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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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