FDA.reportPublic FDA data

Pedigo Products, Inc.

Primary DI
00841027101604
Brand
Pedigo Products, Inc.
Company
PEDIGO PRODUCTS, INC.
Model
DC250L-1L-CA
Device description
DC250L, 120V, CSWRH W/LK, WITH CASTERS, ENTHERMICS
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00841027101604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841027101604008410271016048410271016040841027101604

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008301772
Device count
1
Serial number
true
Manufacturing date on label
true

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
00841027104766Pedigo Products, Inc.EC250L-2BA-MED2026-06-02
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
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
00841027104766Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-06-02
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