AccessGUDID - DEVICE: swiftPro DC power adaptor (05060652910077)

GUDID

Device Identifier (DI) Information

Brand Name: swiftPro DC power adaptor
Version or Model: SWF-DCA01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SWF-DCA01
Company Name: EMBLATION LIMITED

Primary DI Number: 05060652910077
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 211334261 *Terms of Use

Device Description: The swiftPro DC power adaptor is used to power the swiftPro hand-held generator

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):	Yes
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?
45804	Electrical mains power cable	An insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEY	System, Ablation, Microwave And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K222388	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: 56b6427c-f87f-4756-9eab-bd6734293485
Public Version Date: December 12, 2023
Public Version Number: 1
DI Record Publish Date: December 04, 2023