AccessGUDID - DEVICE: Unassembled connector kit For hyperbaric chamber (05700699056603)

GUDID

Device Identifier (DI) Information

Brand Name: Unassembled connector kit For hyperbaric chamber
Version or Model: 905-660
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 905-660
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699056603
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: Unassembled connector kit For hyperbaric chamber

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?
36092	Electrical mains power extension cable	An insulated electrical cord designed with a mains electricity supply plug at one end and single or multiple outlet socket clusters at the other end, intended to enable a connection between a medical device and a mains electricity supply. It is typically used where there is a need for many electrically-powered medical devices, e.g., in the operating room (OR). 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
LPP	Monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: cd33ac9b-c2d2-4464-863c-7188f1bc3f71
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016