AccessGUDID - DEVICE: Isolette TI500 Transport Incubator (04049098000208)

GUDID

Device Identifier (DI) Information

Brand Name: Isolette TI500 Transport Incubator
Version or Model: MU20505
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DRAEGER MEDICAL SYSTEMS, INC.

Primary DI Number: 04049098000208
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788289952 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
36025	Conventional infant incubator	A mains electricity (AC-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 typically consists of a clear removable plastic hood with a mattress. It typically includes a means to warm the infant such as providing heated air (either by natural flow or forced) or through a warm water mattress; temperature controls that work automatically either by measuring the air temperature or through a temperature sensor attached to the infant skin; and humidity controls. The device is intended to remain in a hospital ward.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPL	Incubator, Neonatal Transport

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K941106	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: 67422945-177e-49e6-9c3e-0f6ff74da8e1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2015