FDA.reportPublic FDA data

Coulmed

Primary DI
10810087352834
Brand
Coulmed
Company
Coulmed Products Group LLC
Model
AP220
Catalog number
AP220
Device description
"Armboard Pad, Standard Foam, 2""T x 6""W x 20""L"
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
10810087352834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081008735283410810087352834

GMDN Terms#

Term, Definition table
TermDefinition
Arm procedure positioner, reusableA preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. 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
10810087351080CoulmedCoulmed 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