FDA.reportPublic FDA data

ADVOCATE HEATING PAD KING SIZE

Primary DI
20894046001145
Brand
ADVOCATE HEATING PAD KING SIZE
Company
DIABETIC SUPPLY OF SUNCOAST, INC.
Model
315
Catalog number
JY6101
Device description
ADVOCATE HEATING PAD KING SIZE 12"X 24" AUTO TURN OFF 4 HEAT SETTINGS
Published
2017-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20894046001145PackageGS112In Commercial Distribution
00894046001141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2089404600114520894046001145
00894046001141008940460011418940460011410894046001141

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad whole-body heating systemAn assembly of mains electricity (AC-powered) devices designed to heat a patient's whole body, to compensate for the loss of normal body heat, with heat generated from an externally applied pad typically containing electrical heating elements or cables. The system includes the pad designed to heat under or over the patient, and a control unit to regulate and monitor the heat. The pads are available in a variety of lengths, widths, and thicknesses to accommodate body size and applications (e.g., adult/paediatric, full-/partial-body). The system is typically used in the operating room (OR), the intensive care unit (ICU), or in neonatal and recovery units.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-469-3579lhenry@pharmasupply.com

Regulatory Flags#

DUNS number
043081723
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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
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00894046001875Advocate Redi-Code+ Test Strips for Blood Glucose 35 CountBMB002-35BMB002-352016-08-19
00894046001394Advocate Redi-Code+ Pharmacy Test Strips BMB002-PBMB002-P2016-08-19
00852982006491Advocate Redi-Code+ Test Strips for Blood Glucose 10 countBMB002-10BMB002-102018-03-27
00852982006415ADVOCATE Heating Pad International327-INTLJY65002020-07-10
00894046001141ADVOCATE HEATING PAD KING SIZE315JY61012017-03-10
00894046001554ADVOCATE HEATING PAD CLASSIC SIZE327JY61002017-03-10
00852982006354ADVOCATE ORAL & RECTAL THERMOMETER1451452017-02-06
00894046001042Advocate Non-Contact Infra-red thermometer1401402016-08-22
00894046001516Advocate Blood Pressure Monitor, Wrist, Model SPBP-02, Bilingual403-FG403-FG2016-08-22
00894046001400Advocate Arm BPM S/M CUFF406 S/M406 S/M2016-08-22
00894046001417Advocate Arm BPM L Cuff406L406L2016-08-22
00894046001509American Heart- Tech Non-Speaking Wrist BPMKD-735405-HT2016-08-22
00894046001530Advocate Blood Pressure Monitor Model SPBP-04 Upper Arm XL Cuff406XL406XL2016-08-22
00852982006408Advocate Blood Pressure Monitor Non-Speaking Wrist FT-B05WFT-B05W2017-04-17
00894046001097Advocate Lancets Twist Top 30 Gauge3082020-06-22
00894046001899Advocate Lancets Safety 21 Gauge 2.4mm6342020-06-22
00894046001905Advocate Lancets Safety 23 Gauge6352020-06-22
00894046001912Advocate Lancets Safety 28 Gauge6372020-06-22
00894046001929Advocate Lancets Safety 26 G 1.8 mm6362020-06-22

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