AccessGUDID - DEVICE: Power PRO (07613327513264)

GUDID

Device Identifier (DI) Information

Brand Name: Power PRO
Version or Model: 6506
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 650605550002
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327513264
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?
60487	Ambulance stretcher, electrohydraulic	A battery-powered device consisting of a platform mounted on a wheeled frame, intended for use by emergency medical services (EMS) primarily to facilitate easy transport of a recumbent patient to and from ambulance vehicles (e.g., automobiles, aircraft, boats), whilst allowing the operator to raise and lower the platform using powered switches. It has an electrically-powered hydraulic undercarriage (e.g., X-frame) which can raise/lower the patient and is collapsible for ambulance loading; ambulance-mounted locking/docking devices may be included. The patient platform is typically hydraulically adjustable.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPO	STRETCHER, WHEELED

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
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Handling Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Handling Environment Temperature: between -30 and 130 Degrees Fahrenheit
Storage Environment Temperature: between -30 and 130 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0ecdeb9a-c7f9-4703-a58c-f1614aaacd32
Public Version Date: September 18, 2020
Public Version Number: 1
DI Record Publish Date: September 10, 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
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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