AccessGUDID - DEVICE: PINNACLE (00817650022456)

GUDID

Device Identifier (DI) Information

Brand Name: PINNACLE
Version or Model: SL600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SL600DC
Company Name: Harmar Summit, LLC

Primary DI Number: 00817650022456
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144008062 *Terms of Use

Device Description: Pinnacle Washington State Non Keyed

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):	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?
30038	Stairlift, chair	A mains electricity (AC-powered) lifting device with an attached seating unit to accommodate a person with a disability, a geriatric or an infirm person to be transported up and down a staircase in a sitting position. This electromechanical device is typically attached to one or more rails which follow the shape and angle of the staircase, but may be affixed in another manner. It will typically be installed for home-use and in public venues and institutions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILK	Transport, patient, powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091858	000

Device Exempt from Premarket Submission: No 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: 2f03bffb-9dee-4097-bfc6-9ceac8a95598
Public Version Date: April 19, 2023
Public Version Number: 4
DI Record Publish Date: September 28, 2016

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: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)833-0478
Email: quality_team@harmar.com

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