FDA.reportPublic FDA data

Alleset

Primary DI
06931918143227
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
Model SHTDW5472
Device description
Sheet, draw,54x72in, global_60ea/cs
Published
2021-04-24
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMEBEDDING, DISPOSABLE, MEDICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16931918143224PrimaryGS10
06931918143227Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693191814322416931918143224
06931918143227069319181432276931918143227

GMDN Terms#

Term, Definition table
TermDefinition
Patient transfer/turning sheetA manual device in the form of a sturdy sheet intended to be used by healthcare professionals to assist in the physical movement and/or transfer of a recumbent patient from one position/location to another. The device may operate using sliding/rolling and/or lifting techniques to move the patient upon it. It is typically made of plastics or textiles and may incorporate handles. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+86057383617385link_dong@gri-metc.com

Regulatory Flags#

DUNS number
679894738
Device count
60
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
false
Expiration date on label
false
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
16931918145563Alleseti90-4230-HB2025-11-11
16931918170893Alleset10-0282026-05-08
16931918118994Beaver Visitec Inter603004652022-12-06
16931918122182Invenioi91-61422024-02-12
16931918122380Invenioi91-4320-S12024-02-02
16931918123714Invenioi91-61302024-02-02
16931918124056Invenioi91-4330-S12024-02-02
16931918127064Invenioi90-7032-S12024-02-02
16931918128573Invenioi90-80002022-12-06
16931918129006Invenioi91-4330-HB2024-02-02
16931918129631Invenioi90-80322024-02-17
16931918134277Invenioi91-12422024-02-12
16931918137407Beaver Visitec Inter603004552022-12-05
16931918140926Invenioi90-4220-W1-HB2024-02-17
16931918140995Invenioi91-4320-HB2024-02-12
16931918142562Invenioi91-61242024-02-12
16931918142661Invenioi91-61202024-02-02
16931918143163Invenioi91-6130-W12024-02-12
16931918144641Invenioi91-1230-W1-HB2024-02-12
16931918145457Invenioi91-6130-S12024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918186184InvenioGRI Medical & Electronic Technology Co., Ltd.KME2026-04-29
10304040196660Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196677Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196684Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196691Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196707Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196714Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
16931918105475AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-03-18
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
M68959120030Hypothermia Management SetSafeguard US Operating, LLCKME2025-10-24
10304040193157Henry ScheinHENRY SCHEIN, INC.KME2025-09-03
20192253014423CARDINAL HEALTHCardinal Health 200, LLCKME2025-08-19
16931918194165AllesetGRI Medical & Electronic Technology Co., Ltd.KME2025-06-21
16931918129815HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2025-06-20
10889483602911AirLife™AirLife Finland OyKME2025-04-17
10889483602928AirLife™AirLife Finland OyKME2025-04-17
10889483602935AirLife™AirLife Finland OyKME2025-04-17
10889483602942AirLife™AirLife Finland OyKME2025-04-17
10889483603031AirLife™AirLife Finland OyKME2025-04-17
10889483603048AirLife™AirLife Finland OyKME2025-04-17
10603354120669ComfortTopEHOB INCKME2025-01-22
M68959320040HAWK Advanced Hypothermia Management SetSafeguard US Operating, LLCKME2024-10-08
16931918123400AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
16931918177564AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
16931918177984AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
07613327632835Sage Multi-Position MATSSAGE PRODUCTS, LLCKME2024-08-12
10850053289580SURGYCOSurgyco LLCKME2024-08-09
16931918115214HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11
16931918121987HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11