AccessGUDID - DEVICE: Well Baby Bassinet (00840682119498)

GUDID

Device Identifier (DI) Information

Brand Name: Well Baby Bassinet
Version or Model: BN5
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: DATEX-OHMEDA INC

Primary DI Number: 00840682119498
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 131483356 *Terms of Use

Device Description: SSY-LAU, BASSINET WITH SIDE PANEL, WITH SPACER AND LABELS, CUSTOM-MAKE

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
Storage Environment Temperature: between -25 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a26d557-1e3a-477c-8dd0-073bb988337e
Public Version Date: August 04, 2025
Public Version Number: 4
DI Record Publish Date: July 29, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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