FDA.reportPublic FDA data

S-Monovette®

Primary DI
04038917025942
Brand
S-Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
04.1936.100
Catalog number
04.1936.100
Device description
S-Monovette® 4.9ml LH
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917025942PackageGS150In Commercial Distribution
04038917134767PrimaryGS10
04038917207324Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917025942040389170259424038917025942
04038917134767040389171347674038917134767
04038917207324040389172073244038917207324

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, lithium heparin/mechanical separatorA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, the anticoagulant lithium heparin, and a mechanical separator which provides a physical barrier between plasma and cellular components after centrifugation. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., chemistry determinations, therapeutic drug monitoring, infectious disease testing). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
388000270
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038917240345Safety-Multifly®-Needle85.1638.93585.1638.9352016-09-16
04038917281812Micro-Needle85.92385.9232016-09-16
04038917281843Micro-Needle85.92585.9252016-09-16
04038917315517Micro-Needle85.92185.9212016-09-16
04038917423410Safety-Multifly® 23G w.holder85.1640.93585.1640.9352024-02-20
04038917423892Safety-Multifly®-Needle85.1638.20185.1638.2012019-12-13
04038917423724Multifly®-Needle85.163885.16382019-10-06
04038917423755Multifly®-Needle85.1638.00185.1638.0012019-10-06
04038917423762Multifly®-Needle85.1638.00585.1638.0052019-10-06
04038917423779Multifly®-Needle85.1638.03585.1638.0352019-10-06
04038917423786Multifly®-Needle85.1640.00585.1640.0052019-10-06
04038917423793Multifly®-Needle85.1640.03585.1640.0352019-10-06
04038917423885Safety-Multifly®-Needle85.1638.20085.1638.2002019-09-30
04038917423915Safety-Multifly®-Needle85.1638.20585.1638.2052019-09-30
04038917423922Safety-Multifly®-Needle85.1638.23585.1638.2352019-09-30
04038917423939Safety-Multifly®-Needle85.1640.20085.1640.2002019-09-30
04038917423960Safety-Multifly®-Needle85.1640.20585.1640.2052019-09-30
04038917423977Safety-Multifly®-Needle85.1640.23585.1640.2352019-09-30
04038917423991Safety-Multifly®-Needle85.1642.20585.1642.2052019-09-30
04038917424004Safety-Multifly®-Needle85.1642.23585.1642.2352019-09-30

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