FDA.reportPublic FDA data

Couplet Care Bassinet

Primary DI
00199284746916
Brand
Couplet Care Bassinet
Company
Couplet Care, Inc.
Model
CCB0100
Device description
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.
Published
2026-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NZGBassinet, Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZGBassinet, HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199284746916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199284746916001992847469161992847469160199284746916

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal bedA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081464366
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841027102656Pedigo Products, Inc. PEDIGO PRODUCTS, INC.NZG2025-11-26
00841027102663Pedigo Products, Inc. PEDIGO PRODUCTS, INC.NZG2025-11-26
00841027102670Pedigo Products, Inc. PEDIGO PRODUCTS, INC.NZG2025-11-26
00841027102687Pedigo Products, Inc. PEDIGO PRODUCTS, INC.NZG2025-11-26
00841027102694Pedigo Products, Inc. PEDIGO PRODUCTS, INC.NZG2025-11-26
00841027102700Pedigo Products, Inc. PEDIGO PRODUCTS, INC.NZG2025-11-26
00852788008101NeoLight Bassinet Basket LoanerNEOLIGHT LLCNZG2025-04-09
00852788008217NeoLight Bassinet BasketNEOLIGHT LLCNZG2024-12-31
00850038811945Coleman BassinetBlickman Industries, LLCNZG2022-04-11
00850038811952Coleman BassinetBlickman Industries, LLCNZG2022-04-11
00850038811969Coleman BassinetBlickman Industries, LLCNZG2022-04-11
00850038811976Coleman BassinetBlickman Industries, LLCNZG2022-04-11
00850022426513NB-WFXD-3DL-BRSNOVUM MEDICAL PRODUCTS INCNZG2021-08-16
00724995204495BirkovaSTERIS CORPORATIONNZG2021-06-30
00724995204501BirkovaSTERIS CORPORATIONNZG2021-06-30
00851477007265MedvironMEDVIRON LLCNZG2020-10-23
00851477007227MedvironMEDVIRON LLCNZG2020-05-05
00851477007234MedvironMEDVIRON LLCNZG2020-05-05
00851477007241MedvironMEDVIRON LLCNZG2020-05-05
00851477007258MedvironMEDVIRON LLCNZG2020-05-05
008509250077729000X17TNOVUM MEDICAL PRODUCTS INCNZG2020-02-25
07540162040009THE KERRI BEAR MATERNITY BASSINETImperial Surgical LtdNZG2019-08-07
07540162040016THE KERRI BEAR MATERNITY BASSINETImperial Surgical LtdNZG2019-08-07
07540162040023THE KERRI BEAR MATERNITY BASSINETImperial Surgical LtdNZG2019-08-07
07540162040030THE KERRI BEAR MATERNITY BASSINETImperial Surgical LtdNZG2019-08-07
07540162040047THE KERRI BEAR MATERNITY BASSINETImperial Surgical LtdNZG2019-08-07
07540162040054S/S Tubular frame maternity bassinetImperial Surgical LtdNZG2019-08-07
00887761995055BassinetHILL-ROM, INC.NZG2019-07-09
00850925007710NB-SSxBCNOVUM MEDICAL PRODUCTS INCNZG2019-05-23
00818771000002Bassinest Hospital SeriesHALO INNOVATIONS, INC.NZG2019-03-26