FDA.reportPublic FDA data

Prime Medical LLC

Primary DI
00855085005101
Brand
Prime Medical LLC
Company
Prime Medical LLC
Model
ECP100
Catalog number
ECP100
Published
2023-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855085005101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855085005101008550850051018550850051010855085005101

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078682939
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850055249431Prime Medical LLCPrimePadPlus-K1-212026-03-06
00850055249448Prime Medical LLCPrimePadPlus-K3-212026-03-06
00850055249455Prime Medical LLCPrimePadPlus-K5-212026-03-06
00850055249462Prime Medical LLCPrimePadPlus-K6-212026-03-06
00850055249479Prime Medical LLCPrimePadPlus-K7-212026-03-06
00850055249486Prime Medical LLCPrimePadPlus-K8-212026-03-06
00850055249493Prime Medical LLCPrimePadPlus-W1-212026-03-06
00850055249509Prime Medical LLCPrimePadPlus-W2-212026-03-06
00850055249516Prime Medical LLCPrimePadPlus-k9-212026-03-06
00850055249011Prime Medical LLCPrimePadPlus-K122026-03-05
00850055249028Prime Medical LLCPrimePadPlus-K142026-03-05
00850055249035Prime Medical LLCPrimePadPlus-K152026-03-05
00850055249042Prime Medical LLCPrimePadPlus-1S-212026-03-05
00850055249059Prime Medical LLCPrimePadPlus-K2-212026-03-05
00850055249066Prime Medical LLCPHP1002026-03-05
00850055249103Prime Medical LLCPrimePadPlus-1-212026-03-05
00850055249134Prime Medical LLCPPOST62026-03-05
00850055249141Prime Medical LLCTP-100-HAN2026-03-05
00850055249165Prime Medical LLCDDS1002026-03-05
00850055249172Prime Medical LLCJTK1002026-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196413737MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-04-27
10080196413256MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413485MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413690MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
G242SB03RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB07SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB12RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SS03DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB01RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB05SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB10RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS05DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS08DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS10DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS11DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS15DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
10197344161034MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-07-28
10197344158768MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-06-30
10197344100392MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-04-05
10080196413805MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-01-22