AccessGUDID - DEVICE: Lifestart (05060195340683)

GUDID

Device Identifier (DI) Information

Brand Name: Lifestart
Version or Model: LSU001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INSPIRATION HEALTHCARE GROUP PLC

Primary DI Number: 05060195340683
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 235903494 *Terms of Use

Device Description: Compact LifeStart LSU001

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):	Yes
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

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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
Infant resuscitation table	A flat surface fixed on legs and on which newborn infants who do not breathe spontaneously at birth and are oxygen deficient are placed for emergency resuscitation. It is typically equipped with a heating lamp and sometimes a supplemental heating pad, a low-pressure suction system, an oxygen (O2) supply, a gas mixer (oxygen/air), and a resuscitator. It may be supplied with the resuscitation devices or not, in which case the resuscitation devices are fitted by another party (e.g., hospital clinical engineer, device supplier). This device is typically fixed in one place.

GMDN Preferred Term Name

GMDN Definition

Infant resuscitation table

A flat surface fixed on legs and on which newborn infants who do not breathe spontaneously at birth and are oxygen deficient are placed for emergency resuscitation. It is typically equipped with a heating lamp and sometimes a supplemental heating pad, a low-pressure suction system, an oxygen (O2) supply, a gas mixer (oxygen/air), and a resuscitator. It may be supplied with the resuscitation devices or not, in which case the resuscitation devices are fitted by another party (e.g., hospital clinical engineer, device supplier). This device is typically fixed in one place.

FDA Product Code

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Product Code	Product Code Name
LGX	TABLE, EXAMINATION, MEDICAL, POWERED

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6d60801b-65a8-402b-b16b-08b797dcb421
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 04, 2016