AccessGUDID - DEVICE: Power-LOAD (07613327261523)

GUDID

Device Identifier (DI) Information

Brand Name: Power-LOAD
Version or Model: 6390
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6390-000-000
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327261523
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078470558 *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":	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?
60488	Ambulance stretcher loader	A battery-powered, hydraulically-operated device designed to be installed within an ambulance to support the loading and unloading of an ambulance stretcher, to improve the safety and ease of patient transfer to and from the ambulance. It is typically a semi-automated docking/locking, lifting, and conveying mechanism that may include additional guides and adaptors.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPO	STRETCHER, WHEELED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113598	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
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between -30 and 158 Degrees Fahrenheit
Storage Environment Temperature: between -30 and 158 Degrees Fahrenheit
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cb2f195a-2225-4da7-8f1a-b50776f886ed
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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