FDA.reportPublic FDA data

TA-UPC Ultra Power Cable 3'

Primary DI
00861816000390
Brand
TA-UPC Ultra Power Cable 3'
Company
Estill Medical Technologies, Inc.
Model
TA-UPC
Published
2024-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
BSBWarmer, Blood, Non-Electromagnetic Radiation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSBWarmer, Blood, Non-Electromagnetic RadiationHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861816000390PackageGS125In Commercial Distribution
10861816000342PackageGS1100In Commercial Distribution
00861816000345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861816000390008618160003908618160003900861816000390
1086181600034210861816000342
00861816000345008618160003458618160003450861816000345

GMDN Terms#

Term, Definition table
TermDefinition
Convection blood/fluid warmerAn electrically-powered device designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the convection of heat. The device usually includes an aqueous heat exchanger (e.g., water bath) for the convection of heat to the infusion blood/fluid via a disposable set (e.g., coiled tubing); it also includes temperature controls and/or alarms. The warmer is used to minimize adverse thermal reactions in the patient. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
029148074
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00861816000345TA-UPC Ultra Power Cable 3'TA-UPC2024-03-28
00861816000307Thermal Angel TA-2002023-12-31
00861816000314Thermal Angel TA-2002023-12-31
00861816000338Thermal Angel Ultra Battery 1TA-UB12023-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
507073878034023M™ Ranger™3M COMPANYBSB2026-04-26
07290016740202Warrior AC StationQUALITY IN FLOW LTDBSB2025-02-18
17290016740209QINFLOW AC STATION INTRO SET EXTREMEQUALITY IN FLOW LTDBSB2025-02-18
37290016740166QINFLOW WARRIOR LITE SET WITH LITE BATTERYQUALITY IN FLOW LTDBSB2025-02-18
37290016740203QINFLOW AC STATION INTRO SET WARRIORQUALITY IN FLOW LTDBSB2025-02-18
47290016740163QINFLOW WARRIOR LITE SET WITH 2 LITE BATTERYQUALITY IN FLOW LTDBSB2025-02-18
47290016740200QINFLOW AC STATION EXTENDED SET WARRIORQUALITY IN FLOW LTDBSB2025-02-18
05745000140015°M Warmer System - Starter KitMequ A/SBSB2024-10-30
05745000140022°M Warmer System - Starter Kit+Mequ A/SBSB2024-10-30
05700002076816°M Warmer System - °M WarmerMequ A/SBSB2024-10-09
05700002076823°M Warmer System - °M WarmerMequ A/SBSB2024-10-09
05700002076847°M Warmer System - ChargerMequ A/SBSB2024-10-09
05745000140039°M Warmer System - Power PackMequ A/SBSB2024-10-09
05745000140046°M Warmer System - Power Pack+Mequ A/SBSB2024-10-09
04260114141433ASTOTUBE®Stihler Electronic GmbHBSB2024-08-16
04260114141440ASTOTUBE®Stihler Electronic GmbHBSB2024-08-16
04260114141389ASTOTUBE®Stihler Electronic GmbHBSB2024-08-16
04260114141396ASTOTUBE®Stihler Electronic GmbHBSB2024-08-16
20896128002095buddy™ Disposable SetBELMONT INSTRUMENT CORPORATIONBSB2024-04-15
00861816000345TA-UPC Ultra Power Cable 3'Estill Medical Technologies, Inc.BSB2024-03-28
00861816000307Thermal Angel Estill Medical Technologies, Inc.BSB2023-12-31
00861816000314Thermal Angel Estill Medical Technologies, Inc.BSB2023-12-31
00861816000338Thermal Angel Ultra Battery 1Estill Medical Technologies, Inc.BSB2023-12-31
17290016740162QinFlow Warrior Lite set with 1 Lite Extra Power BatteryQUALITY IN FLOW LTDBSB2023-01-05
27290016740169QinFlow Warrior Lite set with 2 Lite Extra Power BatteryQUALITY IN FLOW LTDBSB2023-01-05
07290016740042AC Power supply ModuleQUALITY IN FLOW LTDBSB2023-01-04
07290016740097QIF-01-12 extended kit QUALITY IN FLOW LTDBSB2023-01-04
07290016740103Warrior Lite Blood and Fluid Warmer Base UnitQUALITY IN FLOW LTDBSB2023-01-04
07290016740110Rechargeable Lite BatteryQUALITY IN FLOW LTDBSB2023-01-04
07290016740134Warrior pole mountingQUALITY IN FLOW LTDBSB2023-01-04