FDA.reportPublic FDA data

Pedigo Products, Inc.

Primary DI
00841027104766
Brand
Pedigo Products, Inc.
Company
PEDIGO PRODUCTS, INC.
Model
EC250L-2BA-MED
Device description
2.5 CU FT STAINLESS FLUID WARMER 120VAC TYPE-B CORD, WINDOW RIGHT HAND DOOR WITHOUT LOCK, WITH FEET WITH 2 BASKETS, MEDLINE BRANDED
Published
2026-06-02
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

Product Codes#

Code, Name table
CodeName
LGZWarmer, Thermal, Infusion Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132202000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132202000DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINETEnthermics Medical Systems, Inc.2013-12-06LGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841027104766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841027104766008410271047668410271047660841027104766

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
008301772
Device count
1
DM exempt
false
Premarket exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841027105749Pedigo Products, Inc.EC1350BL-BI2026-07-24
00841027105725Pedigo Products, Inc.EC350L-1L-CA2026-07-12
00841027105695Pedigo Products, Inc.P-1080-8-RED2026-06-26
00841027104728Pedigo Products, Inc.EC1350BL-1LF-MED2026-05-12
00841027104735Pedigo Products, Inc.EC550BL-18-220-230V-TYPE-L2026-05-12
00841027104742Pedigo Products, Inc.DC250-220-230V-TYPE-I2026-05-12
00841027104759Pedigo Products, Inc.EC1350BL-LH2026-05-12
00841027103233Pedigo Products, Inc.P-1083-82026-01-08
00841027103240Pedigo Products, Inc.P-72022026-01-08
00841027102960OR Specific419-HD-S2025-12-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B286DWC182464TG4B220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243064T4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGLHMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGMBAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TMBAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TMBEL220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TTS4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286SWC1518224B1Single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286SWC151822LHNB1Single CHAMBER WARMING CABINETM.A.C. MEDICAL INC.LGZ2026-08-21
B286SWC242424GNB1Single CHAMBER WARMING CABINETM.A.C. MEDICAL INC.LGZ2026-08-21
B286DWC183074EG4BC1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074EGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074T4BAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074T4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074TGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074TTS4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242464T4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242464TMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474EGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474TG4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474TG4BR2SB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286243074TGMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-17
B286SWC242464GMB1single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-14
00841027105749Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-07-24
00841027105725Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-07-12
00841027104728Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
00841027104735Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
00841027104742Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
00841027104759Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12