Level 1

Primary DI
20695085430015
Brand
Level 1
Company
ICU MEDICAL, INC.
Model
DI-300
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KZLDEVICE, WARMING. BLOOD AND PLASMA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZLDevice, Warming. Blood And PlasmaHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50695085430016PackageGS110In Commercial Distribution
20695085430015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5069508543001650695085430016
2069508543001520695085430015

GMDN Terms#

Term, Definition table
TermDefinition
Convection blood/fluid warmer, high-flowAn electrically-powered device designed for in-line heating of rapidly-infused (may exceed 1 L/min) banked blood, blood products, and intravenous (IV) solutions (crystalloid and colloid), typically from about 4ºC to near body temperature (i.e., 35 to 37ºC), during high-blood-loss surgical procedures and for burn and trauma cases. 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. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709194899BivonaFU26FN35NGE024N2026-06-04
10887709194905BivonaFT26FN40NGE027N2026-06-04
10887709194912BivonaFU26FN40NGE028N2026-06-04
10887709194929BivonaXT26FS50NSF019N2026-06-04
10887709194936BivonaFT26EN40NSF122S2026-06-04
10887709194943BivonaFT26EN40NSF122S2026-06-04
10887709194585BivonaFU26EN60NGA202S2026-06-03
10887709194615BivonaFT26EN50NGA210N2026-06-03
10887709194790BivonaFT26FN35NGE013N2026-06-03
10887709194806BivonaFT26FN35NGF014N2026-06-03
10887709194813BivonaHU26FS50NGF016N2026-06-03
10887709194820BivonaFT26FN45NSA017N2026-06-03
10887709194837BivonaFT26FN30NSF018N2026-06-03
10887709194844BivonaFT26FN35NGE020N2026-06-03
10887709194851BivonaFT26FN30NSE021N2026-06-03
10887709194868BivonaSU26FN50NGF022N2026-06-03
10887709194875BivonaFT26FN35NSF023N2026-06-03
10887709194882BivonaHU26FS45NSB015N2026-06-03
00887709170995ICU Medical, Inc.BAGH012026-06-02
10887709194660BivonaFP26FN45NGF003N2026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20695085001826Level 1ICU MEDICAL, INC.KZL2026-01-08
10695085001829Level 1ICU MEDICAL, INC.KZL2026-01-08
04038917968560SAHARA-TSC 115VSarstedt Aktiengesellschaft & Co.KGKZL2023-11-24
00810144911137RediporAnalytiChem USA, Inc.KZL2023-09-21
04038917968324SAHARA-III basic model 115VSarstedt Aktiengesellschaft & Co.KGKZL2023-06-06
04038917968645SAHARA-III MAXITHERM 115VSarstedt Aktiengesellschaft & Co.KGKZL2023-06-06
04059201001701Barkey plasmatherm VBarkey GmbH & Co. KGKZL2021-11-12
04059201001817Barkey plasmatherm C&GBarkey GmbH & Co. KGKZL2021-11-12
04059201002135Barkey plasmatherm C&GBarkey GmbH & Co. KGKZL2021-11-12
07290115270006ZipThaw™ 202FREMON SCIENTIFIC, INC.KZL2020-03-06
20695085400100Level 1ICU MEDICAL, INC.KZL2019-09-25
30695085400107Level 1SMITHS MEDICAL MD, INC.KZL2019-09-25
50608223241108Bair Hugger™3M COMPANYKZL2017-01-30
35019315057919JelcoSmiths Medical ASD, Inc.KZL2017-01-03
20695085406003Level 1ICU MEDICAL, INC.KZL2016-10-14
20695085410017Level 1ICU MEDICAL, INC.KZL2016-10-14
20695085430008Level 1ICU MEDICAL, INC.KZL2016-10-14
30695085433006Level 1ICU MEDICAL, INC.KZL2016-10-14
40695085400302Level 1ICU MEDICAL, INC.KZL2016-10-14
40695085410004Level 1ICU MEDICAL, INC.KZL2016-10-14
10695085800217Level 1ICU MEDICAL, INC.KZL2016-10-14
10695085406006Level 1Smiths Medical ASD, Inc.KZL2016-10-14
20695085406010Level 1ICU MEDICAL, INC.KZL2016-10-14
50695085410018Level 1SMITHS MEDICAL MD, INC.KZL2016-10-14
10695085430001Level 1Smiths Medical ASD, Inc.KZL2016-10-14
50695085430016Level 1SMITHS MEDICAL MD, INC.KZL2016-10-14
10695085433002Level 1SMITHS MEDICAL MD, INC.KZL2016-10-14
30695085400305Level 1SMITHS MEDICAL MD, INC.KZL2016-10-14
10695085410003Level 1Smiths Medical ASD, Inc.KZL2016-10-14
04059201000001plasmathermBarkey GmbH & Co. KGKZL2016-10-13