FDA.reportPublic FDA data

Level 1

Primary DI
40695085410004
Brand
Level 1
Company
ICU MEDICAL, INC.
Model
D-100
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
10695085410003PackageGS110In Commercial Distribution
40695085410004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1069508541000310695085410003
4069508541000440695085410004

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
10887709208145BivonaFF26JN50NGF242N2026-11-02
10887709208152BivonaFT26JN60NGA245N2026-11-02
10887709208169BivonaAT26JS75NSC244N2026-11-02
10887709208176BivonaFT26JN40NSE240N2026-11-02
10887709208183BivonaFT26JN35NSE241N2026-11-02
10887709208190BivonaFT26JN55NGA246N2026-11-02
10887709208220BivonaFT26KN40NGE002N2026-11-02
10887709208237BivonaFT26KN35NGE001N2026-11-02
10887709208244BivonaFU26KN50NGF008N2026-11-02
10887709208251BivonaSA26KN95SSC006N2026-11-02
10887709208268BivonaSU26KN60NSC005N2026-11-02
10887709208275BivonaXA26KS60NSC009N2026-11-02
10887709207902BivonaFT26JN35NGE209S2026-10-30
10887709207933BivonaFU26JN45NSF227N2026-10-30
10887709207940BivonaAT26JS60NSC229N2026-10-30
10887709207957BivonaST26JN45NGF228N2026-10-30
10887709207964BivonaXT26JN50NGC230N2026-10-30
10887709207971BivonaFT26JN50NGC231N2026-10-30
10887709207988BivonaFT26JN50NGC232N2026-10-30
10887709208015BivonaXT26JS55NGF220N2026-10-30

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
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