FDA.reportPublic FDA data

Meicen

Primary DI
06977071938126
Brand
Meicen
Company
Guangdong Meicen Medical Equipment Co., Ltd.
Model
RC-E4004
Device description
Vacuum Cushion with Open Headrest 110x55cm
Published
2026-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IWEMonitor, Patient Position, Light-Beam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWEMonitor, Patient Position, Light-BeamRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977071938126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977071938126069770719381266977071938126

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum-mould patient positioning systemAn assembly of devices designed to apply a vacuum to a cushion or bag filled with foam-like material that is placed under, on, or around a patients body parts. A vacuum is applied to the contents of the cushion forming a patient specific (custom-made) mould. The moulds can be whole body or selected body parts and help ensure adequate positioning and immobilization of the patient during diagnostic imaging and/or radiation therapy procedures facilitating reproducible positioning for serial procedures. This system typically includes reusable foam-filled bags, cushions, a vacuum unit, hardware, seals, and interfaces used to connect the mould to another patient positioning system (PPS).

Regulatory Flags#

DUNS number
724689169
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977071931271MeicenM30RB-VSA670W2026-06-26
06977071931288MeicenM30RB-VSA672W2026-06-26
06977071931295MeicenM30RB-VSB673W2026-06-26
06977071931301MeicenM3038-SSB480B2026-06-26
06977071931318MeicenM2422-SVA190W2026-06-26
06977071931325MeicenM30RA-SSA610B2026-06-26
06977071931332MeicenM30RB-SSA672B2026-06-26
06977071931349MeicenM30RB-SSB672B2026-06-26
06977071931356MeicenM2422-SVB190W2026-06-26
06977071931363MeicenM30RB-VSB670W2026-06-26
06977071931400MeicenM2422-SUA190BM2422-SUA190B2026-06-26
06977071931417MeicenM3038-SUA480B2026-06-26
06977071931424MeicenM2422-SUA193B2026-06-26
06977071931431MeicenM3038-SUA482B2026-06-26
06977071931448MeicenM24RB-SUA640B2026-06-26
06977071931455MeicenM24RA-SUA581B2026-06-26
06977071931462MeicenM24RB-SSA640B2026-06-26
06977071931479MeicenM24RA-SVA580W2026-06-26
06977071931486MeicenM3038-SVA480W2026-06-26
06977071931493MeicenM24RA-SVB580W2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977071931271MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931288MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931295MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931301MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931318MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931325MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931332MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931349MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931356MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931363MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931400MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931417MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931424MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931431MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931448MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931455MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931462MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931479MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931486MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931493MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931509MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931516MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931523MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931585MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931592MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931608MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931615MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931622MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931639MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931646MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26