FDA.reportPublic FDA data

SAHARA-III basic model 115V

Primary DI
04038917968324
Brand
SAHARA-III basic model 115V
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
97.8710.502
Catalog number
97.8710.502
Published
2023-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
BK010045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK010045000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917968324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917968324040389179683244038917968324

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags#

DUNS number
388000270
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038917134316S-Monovette®04.1910.00104.1910.0012019-09-17
04038917087322S-Monovette®01.163401.16342016-09-16
04038917125147S-Monovette®02.1065.00102.1065.0012016-09-16
04038917130431S-Monovette®05.1553.10005.1553.1002016-09-16
04038917131919S-Monovette®01.1604.10001.1604.1002016-09-16
04038917131926S-Monovette®01.1604.40001.1604.4002016-09-16
04038917132084S-Monovette®01.1608.10001.1608.1002016-09-16
04038917132107S-Monovette®01.1613.10001.1613.1002016-09-16
04038917132114S-Monovette®01.1614.10001.1614.1002022-09-12
04038917132176S-Monovette®03.1628.10003.1628.1002016-09-16
04038917132213S-Monovette®03.1631.10003.1631.1002016-09-16
04038917132251S-Monovette®01.1634.10001.1634.1002016-09-16
04038917132886S-Monovette®06.1666.10006.1666.1002016-09-16
04038917132930S-Monovette®06.1669.00106.1669.0012016-09-16
04038917134279S-Monovette®04.1906.10004.1906.1002016-09-16
04038917134293S-Monovette®04.1907.10004.1907.1002016-09-16
04038917134330S-Monovette®04.1913.10004.1913.1002016-09-16
04038917134378S-Monovette®04.1920.10004.1920.1002016-09-16
04038917134767S-Monovette®04.1936.10004.1936.1002016-09-16
04038917241779S-Monovette®04.1940.10004.1940.1002016-09-16

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
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
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