FDA.reportPublic FDA data

Pinnakle Moderate Underpad

Primary DI
08938504806793
Brand
Pinnakle Moderate Underpad
Company
PHU BAO GROUP COMPANY LIMITED
Model
50
Device description
Pinnakle Moderate Underpads are intended for use in protecting patients and elderly individuals experiencing urinary incontinence, individuals undergoing post-operative, postpartum women, and newborns
Published
2025-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
08938504806793PrimaryGS10
08985048067937Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08938504806793089385048067938938504806793
08985048067937089850480679378985048067937

GMDN Terms#

Term, Definition table
TermDefinition
Absorbent underpad, non-antimicrobial, single-useA 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 table
Method

Regulatory Flags#

DUNS number
555240671
Device count
50
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885914997567DRY PAD"36"" x 57"" (91.4cm x 144.8cm), 5/PK"2026-03-17
00885914997604DRY PAD"30"" x 36” (76.2cm x 91.4cm), 5/PK"2026-03-17
08859149975678DRY PAD36" x 57" (91.4cm x 144.8cm), 5/PK2026-03-17
00885914997581DRY PAD"23"" x 36"" (58.4cm x 91.4cm), 10/PK"2026-03-17
08859149976040DRY PAD30" x 36” (76.2cm x 91.4cm), 5/PK2026-03-17
08938504806816Perfetta Ultra Face MaskWhite individual packed, 35pcs2020-11-17
08938504806823Perfetta Ultra Face MaskBlue, 50pcs2020-11-17
08938504806649Perfetta Ultra Face MaskBlue individual packed, 35pcs2020-06-25
08938504806786Perfetta Ultra Face MaskWhite, 50pcs2020-06-25
08938504806045Familex Face MaskWhite2020-08-10
08938504806069Familex Face MaskBlue2020-08-10
08938504806076Perfetta Face MaskGreen2020-08-10
08938504806083Familex Face MaskPink2020-08-10
08938504806090Familex Face MaskYellow2020-08-10
89385048060450Familex Face MaskWhite2020-08-10
89385048060696Familex Face MaskBlue2020-08-10
89385048060764Perfetta Face MaskGreen2020-08-10
89385048060832Familex Face MaskPink2020-08-10
89385048060900Familex Face MaskYellow2020-08-10
08938504806052Perfetta Face MaskModerate Green2020-06-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
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00199536911147BluelineTransparent Supply Solutions Ltd.KME2026-05-15
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00199536911161BluelineTransparent Supply Solutions Ltd.KME2026-05-15
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