Couplet Care Bassinet

GUDID 00199284746916

The Couplet Care Bassinet is for use in hospitals and birthing centers. It creates a bridge for mother-infant connection. This access is important for infant feeding, safe sleep, and maternal healing.

Couplet Care, Inc.

Neonatal bed
Primary Device ID00199284746916
NIH Device Record Keyb2358173-1a67-49b3-8e55-04c6b73bd7cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCouplet Care Bassinet
Version Model NumberCCB0100
Company DUNS081464366
Company NameCouplet Care, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100199284746916 [Primary]

FDA Product Code

NZGBassinet, Hospital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-29
Device Publish Date2026-01-21

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.