AccessGUDID - DEVICE: LMT nomag® IC 1.5 (04260486610018)

GUDID

Device Identifier (DI) Information

Brand Name: LMT nomag® IC 1.5
Version or Model: 0100010
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: LMT Medical Systems GmbH

Primary DI Number: 04260486610018
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 312688686 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
35121	Transport infant incubator	An electrically-powered unit designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature; it is typically on wheels and also designed for transporting infants either outside or within the healthcare facility. It typically consists of a clear removable plastic hood with a mattress and operates using mains electricity (AC-powered) when not in use for transportation. During transport, it is connected to an ambulance electrical outlet or is battery-powered from a battery pack.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPL	Incubator, Neonatal Transport

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033565	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: b16d3251-d52c-4b6d-91e4-37b4bad17c4a
Public Version Date: November 06, 2023
Public Version Number: 4
DI Record Publish Date: December 23, 2016