FDA.reportPublic FDA data

Level 1

Primary DI
50695085002930
Brand
Level 1
Company
ICU MEDICAL, INC.
Model
H-31-ES
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
50695085002930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5069508500293050695085002930

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
10887709197265BivonaZU26FN35NGE229N2026-07-09
10887709197289BivonaFT26FN70NSZ232N2026-07-09
10887709197838BivonaFT26GN55NGF037N2026-07-09
10887709197845BivonaST26GN55NGF038N2026-07-09
10887709197852BivonaFT26GN35NSF039N2026-07-09
10887709197869BivonaFT26GN35NSF043N2026-07-09
10887709197876BivonaFT26GN40NSF042N2026-07-09
10887709197883BivonaFU26GN35NGE044N2026-07-09
10887709197890BivonaFU26GN30NGE045N2026-07-09
10887709197906BivonaFP26GN25NGE046N2026-07-09
10887709197135BivonaXT26FS60NGC231N2026-07-08
10887709197142BivonaFT26FN35NGC234N2026-07-08
10887709197203BivonaFT26FN55NGC237N2026-07-08
10887709197210BivonaFT26FN35NSF236N2026-07-08
10887709197227BivonaFT26FN40NGE238N2026-07-08
10887709197234BivonaFT26FN40NGE239N2026-07-08
10887709197241BivonaFT26FN60NGC240N2026-07-08
10887709197722BivonaHT26GS70NSC029N2026-07-08
10887709197739BivonaFT26GN35NSE030N2026-07-08
10887709197746BivonaFT26GN30NSF031N2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
507073878034023M™ Ranger™3M COMPANYBSB2026-04-26
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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