FDA.reportPublic FDA data

Level 1

Primary DI
50695085829261
Brand
Level 1
Company
ICU MEDICAL, INC.
Model
H-31-EN
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BSBWarmer, blood, non-electromagnetic radiation

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK020043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK020043000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50695085829261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5069508582926150695085829261

GMDN Terms#

Term, Definition table
TermDefinition
Blood/fluid warmer air/foam detectorA mains electricity (AC-powered) device that is typically a module or a component of a high-flow blood/fluid warmer, and that provides an alarm and/or stops the flow of fluid when it detects air or foam in the de-aeration chamber of the blood/fluid warming set and/or when the fluid level in the de-aeration chamber is too low.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709197395BivonaFU26FN35NGE250N2026-07-06
10887709197401BivonaFU26FN30NGE251N2026-07-06
10887709197418BivonaSU26FN80NSC252N2026-07-06
10887709197425BivonaFT26FN45NGC256N2026-07-06
10887709197432BivonaFU26FN50NGC254N2026-07-06
10887709197449BivonaFT26FN50NGC255N2026-07-06
10887709197456BivonaFT26GN35NGE001N2026-07-06
10887709197463BivonaFT26GN40NGE002N2026-07-06
10887709197470BivonaFT26GN35NSA003N2026-07-06
10887709197487BivonaFU26GN40NSF004N2026-07-06
10887709197494BivonaXA26GS60NSC005N2026-07-06
10887709197500BivonaSA26GN60NSC006N2026-07-06
10887709197517BivonaSA26GN60NSC007N2026-07-06
10887709197524BivonaSA26GN60NSC008N2026-07-06
10887709197531BivonaSA26GN60NSC009N2026-07-06
10887709197548BivonaST26GN60NSC010N2026-07-06
10887709197555BivonaFU26GN50NSF011N2026-07-06
10887709197562BivonaFU26GN50NSF012N2026-07-06
10887709197579BivonaFT26GN35NGF013N2026-07-06
15019517382860ICU Medical, Inc.011-100/892/200CZ2026-07-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00861816000390TA-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