FDA.reportPublic FDA data

Plastipad® Infant Size

Primary DI
10613031821925
Brand
Plastipad® Infant Size
Company
Gentherm Medical, LLC
Model
193CPC
Catalog number
82192
Device description
Water Circulating Hot or Cold Pack
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, Hot Or Cold, Water Circulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10613031821925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061303182192510613031821925

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid whole-body heating/cooling system pad, reusableAn underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated with the intention to heat and alternatively cool a patient’s whole-body (i.e., elevate or lower core body temperature) as part of a circulating-fluid whole-body heating/cooling system typically used in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric). It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18.75Inch
Weight0.4Pound
Width11.88Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius42 Degrees Celsius
Handling Environment Temperature59 Degrees Fahrenheit107 Degrees Fahrenheit
Storage Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius65.6 Degrees Celsius
Storage Environment Temperature-40 Degrees Fahrenheit150 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-989-7373csz@genthermcsz.com

Regulatory Flags#

DUNS number
004249462
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10613031871074Blanketrol233871072024-06-25
20613031838739Maxi-Therm Lite 873-USME873-USME2024-05-13
20613031838746Maxi-Therm Lite 874-USME874-USME2024-05-13
20613031838760Maxi-Therm Lite 876-USME876-USME2024-05-13
20613031839002Kool-Kit 900-USME900-USME2024-05-13
20613031839200Kool-Kit 920-USME920-USME2024-05-13
20613031839309Kool-Kit 930-USME930-USME2024-05-13
20613031839507Kool-Kit 950-USME950-USME2024-05-13
10613031873078Blanketrol2332332024-05-13
10613031838732Maxi-Therm Lite 873-USME873-USME2024-05-13
10613031838749Maxi-Therm Lite 874-USME874-USME2024-05-13
10613031838763Maxi-Therm Lite 876-USME876-USME2024-05-13
10613031839005Kool-Kit 900-USME900-USME2024-05-13
10613031839203Kool-Kit 920-USME920-USME2024-05-13
10613031839302Kool-Kit 930-USME930-USME2024-05-13
10613031839500Kool-Kit 950-USME950-USME2024-05-13
20613031812432FilteredFlo® PACU Adult Blanket243812432022-08-22
20613031812449FilteredFlo® Pediatric Blanket244812442022-08-22
20613031832430FilteredFlo® PACU Adult Blanket243832432017-08-30
20613031832461FilteredFlo® Neonate/Pediatric Blanket246832462022-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197344214740MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214757MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214733MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-08
06973641887146CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641888518CryoRxChengdu Cryo-push Medical Technology Co.,Ltd.ILO2025-09-16
00311917069159WalgreensWALGREEN CO.ILO2025-08-22
00810113577517ViveVIVE HEALTH LLCILO2024-08-20
00810041987617ViveVIVE HEALTH LLCILO2024-07-17
10850007350090Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350106Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350120Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350073Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350110T/PadC2DX, INC.ILO2024-01-09
00810041981523ViveVIVE HEALTH LLCILO2023-08-07
08809802644038CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644045CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644021CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-12
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00812120001436Game Ready Left Shoulder Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001535Game Ready Straigh Knee Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001542Game Ready Articulated Knee Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001566Game Ready Ankle Wrap - Large - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001580Game Ready Shoulder Wrap - Medium - Right - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001597Game Ready Shoulder Wrap - Medium - Left - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001603Game Ready Shoulder Wrap - Large - Right - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001634Game Ready C-T Spine Wrap - Large - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001658Game Ready Hip/Groin Wrap - Left - DemoAvanos Medical, Inc.ILO2023-04-05
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