AccessGUDID - DEVICE: Bassinest (00818771039606)

GUDID

Device Identifier (DI) Information

Brand Name: Bassinest
Version or Model: 3957
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HALO INNOVATIONS, INC.

Primary DI Number: 00818771039606
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825255706 *Terms of Use

Device Description: The HALO Hospital Bassinest is designed to be a sleeping surface for infant/newborn patients. The top surface of the device raises and lowers to allow easier access to the infant/newborn. The HALO Hospital Bassinest was also designed for in-hospital transport within newborn labor/delivery units, postpartum units, medical surgical units treating high risk pregnancy patients, NICU’s, and any other patient areas within a hospital where a newborn infant may be treated and/or cared for during hospital admissions. This product is NOT INTENDED for patients that can crawl or reposition themselves independently

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?
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
FMS	Bed, Pediatric Open 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: 5156c79d-06cf-4e9f-aa98-24b7e06bca2f
Public Version Date: June 17, 2022
Public Version Number: 2
DI Record Publish Date: August 20, 2018