FDA.reportPublic FDA data

Alleset

Primary DI
06931918172357
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
BM4884-COVER
Device description
Bariatric Mattress Cover_49inX85in_Bulk_N/S_12EA/CS
Published
2022-11-23
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
FMWCover, Mattress (Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMWCover, Mattress (Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16931918172354PrimaryGS10
06931918172357Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693191817235416931918172354
06931918172357069319181723576931918172357

GMDN Terms#

Term, Definition table
TermDefinition
Operating room turnover kitA collection of devices intended to be used to efficiently clean and prepare an operating room (OR) for a subsequent surgical procedure. It typically includes patient oriented items such as absorbent covers/drapes for the operating table and patient positioners (e.g., headrest), operating room cleaning items such as cleaning mop heads and pads, and refuse containment items such as surgical waste and biohazard bags/buckets. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
679894738
Device count
12
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
26931918108718AllesetAGH1X5002026-03-16
06931918122109Alleset15-0500-C2026-02-13
26931918173501Invenioi80-11114G-S2026-02-13
26931918101047AllesetSM5052026-02-09
26931918108411AllesetSM4042026-02-09
26931918139798Alleset99-UPSE2436-N2026-02-09
26931918152353AllesetSM3032026-02-09
26931918161324AllesetSM1012026-02-09
26931918171170AllesetMV-0796EV-S2026-02-09
26931918172931AllesetSM2022026-02-09
26931918141807Alleset44-0796PV-VE-S12026-02-05
26931918105694InvenioGOL0602026-01-21
16931918108155Alleset41-54542026-01-21
26931918125968AllesetCS-6512026-01-21
26931918143498AllesetCS-6502026-01-21
06931918157019Alleset30-015142026-01-21
16931918174334Alleset70-501322026-01-21
26931918184279AllesetCS-6522026-01-21
06931918102354Alleset25-0005-BL-C2025-12-16
26931918171255AllesetC-2015-NS2025-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850045714581Soteria Mattress BarrierTrinity Guardion, Inc.FMW2026-03-10
00840828195898BED COVER-4X36X84-PROGRESSA PULM TOP-PCCURBELL MEDICAL PRODUCTS, INC.FMW2026-01-20
07640178061446CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061736CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061828CT Table CoverPearl Technology AGFMW2025-12-17
07640178061835CT Table CoverPearl Technology AGFMW2025-12-17
07640178061842CT Table CoverPearl Technology AGFMW2025-12-17
07640178061927CT Table CoverPearl Technology AGFMW2025-12-17
07640178061934CT Table CoverPearl Technology AGFMW2025-12-17
07640178061941CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061958CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061965CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061972CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061989CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061996CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062009CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062016CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062023CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062030CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062047CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062054CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062061CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062184CT Table CoverPearl Technology AGFMW2025-12-17
07640178062191CT Table CoverPearl Technology AGFMW2025-12-17
07640178062207CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062214CT Table CoverPearl Technology AGFMW2025-12-17
00850045714536Soteria Neonatal Mattress BarrierTrinity Guardion, Inc.FMW2025-08-18
00840828194433BED COVER 8X36X86 P500 VC STEP DECK - PCCURBELL MEDICAL PRODUCTS, INC.FMW2025-08-11
00818323020403SuresVIVE HEALTH LLCFMW2025-07-09
00818323020410SuresVIVE HEALTH LLCFMW2025-07-09