AccessGUDID - DEVICE: Incubator Attachment Plates (00810050862929)

GUDID

Device Identifier (DI) Information

Brand Name: Incubator Attachment Plates
Version or Model: AS1-020-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIFEPORT, LLC

Primary DI Number: 00810050862929
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 556196210 *Terms of Use

Device Description: INSTALLATION, INCUBATOR * DRAEGER TI500, (INCUBATOR ATTACHMENT PLATES) (SET OF TWO)

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?
43621	Desk mount	A non-dedicated (general-purpose) manually-operated structure designed to be fixed to a desk or a worktop and onto which another medical device (not included) is intended to be safely affixed or mounted. This device is typically clamped (i.e., removable) or permanently screwed to the desk or a worktop surface.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOX	Stand, Infusion

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4e75a1c9-87c7-454d-8443-0a860519fb39
Public Version Date: June 21, 2024
Public Version Number: 1
DI Record Publish Date: June 13, 2024