Level 1

Primary DI
20695085406010
Brand
Level 1
Company
ICU MEDICAL, INC.
Model
DI-60HL
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK860023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK860023000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10695085406013PackageGS110In Commercial Distribution
20695085406010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1069508540601310695085406013
2069508540601020695085406010

GMDN Terms#

Term, Definition table
TermDefinition
Convection blood/fluid warmer, high-flowA mains electricity (AC-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 4?C to near body temperature (i.e., 35 to 37?C), 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.

Sterilization Methods#

Method table
Method

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
00887709098602ICU Medical, Inc.DS19022026-05-28
10887709194431BivonaFU26EN35NGE188N2026-05-28
10887709194448BivonaFU26EN35NGE189N2026-05-28
10887709194455BivonaXT26ES70NSC190N2026-05-28
10887709194462BivonaSU26EN50NGF192N2026-05-28
10887709194486BivonaFT26EN35NGF193N2026-05-28
10887709194509BivonaFT26EN40NGF194N2026-05-28
10887709194226BivonaFT26EN35NSF182N2026-05-27
10887709194233BivonaFU26EN40NGA184N2026-05-27
10887709194240BivonaFT26EN60NSA185N2026-05-27
10887709194356BivonaFT26EN40NSF186N2026-05-27
00887709008045ICU MedicalB33382017-04-17
10887709194219BivonaFU26EN60NGC168N2026-05-26
10887709194141BivonaFT26EN40NGE171N2026-05-22
10887709194158BivonaSU26EN45NGG172N2026-05-22
10887709194165BivonaFU26EN35NGF174N2026-05-22
10887709194172BivonaFT26EN40NGF176N2026-05-22
10887709194189BivonaSU26EN50NGF175N2026-05-22
10887709194196BivonaFT26EN70NSC177N2026-05-22
10887709194073BivonaHT26ES60NSC163N2026-05-21

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
20695085430015Level 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
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