FDA.reportPublic FDA data

Prism Microclimate Pad

Primary DI
00860015694799
Brand
Prism Microclimate Pad
Company
Prism Pacific Industries LLC
Model
PMC100001
Device description
Microclimate Underpad 35"x57"
Published
2026-08-27
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

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
00860015694799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015694799008600156947998600156947990860015694799

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.

Contacts#

Phone, Email table
PhoneEmail
(888) 492-3277jesse@prismpacific.com

Regulatory Flags#

DUNS number
131399422
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
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
00860012736034Prism Lift Seated SlingPLS1000ME2026-08-27
00860012736072Prism Lift Seated SlingPLS1000LG2026-08-27
00860012736089Prism Lift Seated SlingPLS1000EX2026-08-27
00860015694713Prism WedgePWW1001652026-08-27
00860015694720Prism WedgePWW1001992026-08-27
00860015694737Prism WedgePWW1001912026-08-27
00860015694744Prism WedgePWT1001652026-08-27
00860015694751Prism WedgePWT1001992026-08-27
00860015694768Prism WedgePWT1001912026-08-27
00860015694775Prism SlidePSS1000802026-08-27
00860015694782Prism SlidePSS1000452026-08-27
00860016216051Prism Glide RepoPGR1010402026-08-12
00860016315631Prism Air CartPAC1000012026-08-27
00199874887180Prism AirPAP1000012026-07-10

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Primary DI, Brand, Company table
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00199972000573CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
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00840117350069Pillow Cases, Polypropylene/Polyethylene 2-ply, Black, 21" x 30"Dynarex CorporationKME2026-07-31
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00840456206362JMUJMU DENTAL, INCKME2026-07-06
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)Dynarex CorporationKME2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)Dynarex CorporationKME2026-06-08
16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
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10304040196714Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
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