FDA.reportPublic FDA data

RESUABLE INCONTINENCE UNDERPAD

Primary DI
06950471320067
Brand
RESUABLE INCONTINENCE UNDERPAD
Company
Hangzhou A-Tek Medical & Textiles Co., Ltd.
Model
28019
Device description
RESUABLE INCONTINENCE UNDERPAD, PROTECT BEDDING FROM GETTING STAINED DURING USE, PROTECT PATIENT FROM CROSS-INFECTION CAUSED BY BEDDING
Published
2023-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EYQGarment, Protective, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06950471320067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950471320067069504713200676950471320067

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence pants, reusableAn underwear intended to help manage urine and/or stool leakage in incontinent adults and older children. It typically consists of a man’s brief or woman’s panty with external softness and shape resembling regular underwear; some types have a liner, or are designed with an integrated opening to allow the passage of stool into an disposable collection bag/pouch via a flange or noninvasive tube; the collection pouch may be supplied with the pants. The device is intended to be used by patients in healthcare facilities and at home or similar environment. This is a reusable device.

Regulatory Flags#

DUNS number
547874292
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
06950471300137DISPOSABLE HOT OR COLD PACK COVER280302023-07-21
06950471300144VACUUM COLLECTION BOTTLE280312023-07-21
06950471300151GAS COLLECTING VESSEL280322023-07-21
06950471300038DISPOSABLE BEDDING PRODUCTS280202023-07-18
06950471300045EXAMINATION GOWN280212023-07-18
06950471300052SURGICAL CAP280222023-07-18
06950471300069SURGICAL APPAREL ACCESSORY280232023-07-18
06950471300076OPERATING-ROOM SHOE COVER280242023-07-18
06950471300083SURGICAL GOWN280252023-07-18
06950471300106NON-SURGICAL ISOLATION GOWN280272023-07-18
06950471300113TABLE TRAY FOR OPERATING ROOM280282023-07-18
06950471300120CONDUCTIVE SHOE AND SHOE COVER280292023-07-18

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Primary DI, Brand, Company table
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