AccessGUDID - DEVICE: Restraint strap, replacement, carton of 10 (04049098000413)

GUDID

Device Identifier (DI) Information

Brand Name: Restraint strap, replacement, carton of 10
Version or Model: MU06011
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DRAEGER MEDICAL SYSTEMS, INC.

Primary DI Number: 04049098000413
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

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Product Code	Product Code Name
FPL	Incubator, Neonatal Transport
FMQ	Restraint, Protective

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: 0ab59fe7-21c3-43c0-b811-8f8e7a0a8f8c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2015