AccessGUDID - DEVICE: NeoLight Bassinet Basket Loaner (00852788008101)

GUDID

Device Identifier (DI) Information

Brand Name: NeoLight Bassinet Basket Loaner
Version or Model: 300064
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NEO-BASK-LNR
Company Name: NEOLIGHT LLC

Primary DI Number: 00852788008101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 074301687 *Terms of Use

Device Description: The NeoLight Bassinet Basket Loaner is a component of a non-powered medical bassinet, intended to work effortlessly with Stryker’s Nära Bassinet’s wheeled base and mattress, offering an adjustable sleeping surface for infants. Constructed from clear, durable, BPA-free high-impact resistant plastic, the basket features an open top and four fixed walls to securely hold the pediatric patient.

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):	Yes
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
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: a27c8a69-2811-4bb7-92ab-8ed0001edf38
Public Version Date: April 17, 2025
Public Version Number: 1
DI Record Publish Date: April 09, 2025