FDA.reportPublic FDA data

S-Monovette®

Primary DI
04038917523318
Brand
S-Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
04.1953.100
Catalog number
04.1953.100
Device description
S-Monovette® 4.0ml LH-Gel+
Published
2019-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
04038917523318PrimaryGS10
04038917523325Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917523318040389175233184038917523318
04038917523325040389175233254038917523325

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, lithium heparin/gel separatorA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, the anticoagulant lithium heparin and a gel to separate plasma from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., plasma chemistry determinations). 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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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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