FDA.report

Pedigo Products, Inc.

Primary DI
00841027101109
Brand
Pedigo Products, Inc.
Company
PEDIGO PRODUCTS, INC.
Model
EC1540-WB
Device description
EC1540, 120V, CSWRH, WITH CASTERS, WITH BUMPER, ENTHERMICS
Published
2025-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LHCWarmer, Irrigation Solution

Product Code Classifications

CodeDeviceSpecialtyClass
LHCWarmer, Irrigation SolutionPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841027101109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841027101109008410271011098410271011090841027101109

GMDN Terms

TermDefinition
Multi-purpose warming cabinet, stationaryA mains electricity (AC-powered) device designed to warm various items and products prior to use, e.g., bags of irrigation or intravenous (IV) solutions, blankets or clothing to cover or put onto a patient, or clothing for the operating room (OR) personnel to adorn. It typically consists of a heat insulated enclosure with a sealing door, shelves, heating element(s), a thermostat and operating controls. This is a freestanding cabinet (tabletop or floor design) that is designed to be stationary and used in one location. It may also be used in a laboratory.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008301772
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DIBrandModelCatalogPublished
00841027103233Pedigo Products, Inc.P-1083-82026-01-08
00841027103240Pedigo Products, Inc.P-72022026-01-08
00841027101604Pedigo Products, Inc.DC250L-1L-CA2025-12-08
00841027102298Pedigo Products, Inc.IVNOW2-EPM-TYPE-J2025-12-08
00841027102311Pedigo Products, Inc.IVNOW2-EPM-TYPE-N2025-12-08
00841027102328Pedigo Products, Inc.IVNOW2-MED2025-12-08
00841027102335Pedigo Products, Inc.IVNOW32025-12-08
00841027102342Pedigo Products, Inc.IVNOW3-EPM-TYPE-B2025-12-08
00841027102359Pedigo Products, Inc.IVNOW3-EPM-TYPE-DM2025-12-08
00841027102366Pedigo Products, Inc.IVNOW3-EPM-TYPE-EF2025-12-08
00841027102373Pedigo Products, Inc.IVNOW3-EPM-TYPE-G2025-12-08
00841027102380Pedigo Products, Inc.IVNOW3-EPM-TYPE-H2025-12-08
00841027102397Pedigo Products, Inc.IVNOW3-EPM-TYPE-I2025-12-08
00841027102403Pedigo Products, Inc.IVNOW3-EPM-TYPE-J2025-12-08
00841027102410Pedigo Products, Inc.IVNOW3-EPM-TYPE-L2025-12-08
00841027102427Pedigo Products, Inc.IVNOW3-EPM-TYPE-N2025-12-08
00841027102434Pedigo Products, Inc.IVNOW3-MED2025-12-08
00841027102830Pedigo Products, Inc.P-2112-1L2025-12-08
00841027102847Pedigo Products, Inc.P-2112-2BA2025-12-08
00841027102854Pedigo Products, Inc.P-2112-LH1L-2BA2025-12-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00841027100485Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027100508Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027101000Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027101307Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027101314Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102793Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102809Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102816Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102823Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027103059Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
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