AccessGUDID - DEVICE: THE KERRI BEAR MATERNITY BASSINET (07540162040016)

GUDID

Device Identifier (DI) Information

Brand Name: THE KERRI BEAR MATERNITY BASSINET
Version or Model: PH-2695SP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PH-2695SP
Company Name: Imperial Surgical Ltd

Primary DI Number: 07540162040016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 245253575 *Terms of Use

Device Description: This silverpine (light green) bassinet is designed and skillfully crafted to fit perfectly into the maternity ward of your hospital. Manufactured from the highest quality materials to provide a safe and comfortable surrounding for the infant.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
38140	Neonatal bed	A bed designed for newborn babies. It is usually an open rectangular receptacle, and mounted on a wheeled framework (trolley). It is padded or lined with appropriate bedding and used mostly as the general-purpose or standard baby bed in birthing departments. A source of additional heating may be provided to the newborn.	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: eb1fd253-8c3c-4004-84d9-bab56cc52b8f
Public Version Date: June 17, 2022
Public Version Number: 2
DI Record Publish Date: August 07, 2019