AccessGUDID - DEVICE: Medviron Bassinet (10851477007095)

GUDID

Device Identifier (DI) Information

Brand Name: Medviron Bassinet
Version or Model: St Clair Bassinet 2 Drawer
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M22-0000-0000
Company Name: MEDVIRON LLC

Primary DI Number: 10851477007095
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079795848 *Terms of Use

Device Description: St Clair Bassinet with 2 Drawers

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?
60920	Infant-hammock bed mattress	A foam-filled case with a central meshed/netted depression/hole designed to be placed in a cot/crib/bassinet/bed/incubator and to cradle a young infant during sleep/rest, and can used for phototherapy, transportation and burns patients. It is available in various shapes and sizes and is not intended to be placed on an existing mattress. The breathable netting is intended to help reduce the risk of infant injuries/disorders such as suffocation, flat head (plagiocephaly), sudden infant death syndrome (SIDS), pressure sores, and hyperthermia. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NZG	Bassinet, Hospital

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: a32ce6b2-b46d-4def-919d-e3fc6bdf2928
Public Version Date: July 16, 2018
Public Version Number: 1
DI Record Publish Date: June 13, 2018