FDA.report

Alleset

Primary DI
06931918138773
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
Model UIMP4090-1
Device description
Allesorb Underpad_Impervious__40"x90"/102x229cm_non-sterile_Bulk Packed_100ea/cs
Published
2021-02-27
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

Related Records

Contact Domains

Product Codes

CodeName
FRLFiber, Medical, Absorbent
KMEBEDDING, DISPOSABLE, MEDICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16931918138770PrimaryGS10
06931918138773Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1693191813877016931918138770
06931918138773069319181387736931918138773

GMDN Terms

TermDefinition
Absorbent underpad, non-antimicrobialA flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+86057383617385link_dong@gri-metc.com

Regulatory Flags

DUNS number
679894738
Device count
100
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

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26931918125968AllesetCS-6512026-01-21
26931918143498AllesetCS-6502026-01-21
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26931918184279AllesetCS-6522026-01-21
06931918102354Alleset25-0005-BL-C2025-12-16
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