FDA.reportPublic FDA data

Coulmed

Primary DI
10810087351080
Brand
Coulmed
Company
Coulmed Products Group LLC
Model
GP120
Catalog number
GP120
Device description
Bassinet Gel Pad (Neo-Natal), 26' x 12' x 1/2', per each
Published
2023-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LWGSURGICAL TABLE CUSHION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810087351080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081008735108010810087351080

GMDN Terms#

Term, Definition table
TermDefinition
Gel-filled bed mattress overlayA gel-filled pad or thin mattress, usually full-body length, which is placed on top of a bed mattress to distribute an occupant's body weight over a large surface area, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. This is a reusable device.

Regulatory Flags#

DUNS number
047115479
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810087352605CoulmedAC28-PAC28-P2023-01-06
10810087352612CoulmedAC3300-BPAC3300-BP2023-01-06
10810087352629CoulmedAC3400-BPAC3400-BP2023-01-06
10810087352636CoulmedAC3800-BPAC3800-BP2023-01-06
10810087352643CoulmedAC3800-BP-LAC3800-BP-L2023-01-06
10810087352650CoulmedAC3800-BP-RAC3800-BP-R2023-01-06
10810087352667CoulmedAC3900-BPAC3900-BP2023-01-06
10810087350007CoulmedDI-5403DI-54032023-01-06
10810087350014CoulmedDI-5404DI-54042023-01-06
10810087350021CoulmedDI-5406DI-54062023-01-06
10810087350038CoulmedDI-5408DI-54082023-01-06
10810087350045CoulmedDI-5414DI-54142023-01-06
10810087350052CoulmedDI-5415DI-54152023-01-06
10810087350069CoulmedDI-5416DI-54162023-01-06
10810087350076CoulmedDI-5419DI-54192023-01-06
10810087350083CoulmedDI-5420DI-54202023-01-06
10810087350090CoulmedDI-5424DI-54242023-01-06
10810087350106CoulmedDI-5503DI-55032023-01-06
10810087350113CoulmedDI-6101DI-61012023-01-06
10810087350120CoulmedDI-6102DI-61022023-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810087350946CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087350953CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087350960CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087353343CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087354005CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087350908CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350915CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350922CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350939CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350977CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350984CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350991CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351004CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351028CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351035CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351042CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351059CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351066CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351097CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351387CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352001CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352162CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352179CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352186CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352193CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352209CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352216CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352223CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352230CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352247CoulmedCoulmed Products Group LLCLWG2023-01-06