FDA.reportPublic FDA data

S-Monovette®

Primary DI
04038917085557
Brand
S-Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
05.1167
Catalog number
05.1167
Device description
2,7ML S-MONOV. EDTA
Published
2016-09-15
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
04038917004190PackageGS1500In Commercial Distribution
04038917085557PrimaryGS10
04038917167635Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917004190040389170041904038917004190
04038917085557040389170855574038917085557
04038917167635040389171676354038917167635

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, K3EDTAA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant tripotassium ethylene diamine tetraacetic acid (K3EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., whole blood haematology such as complete blood count (CBC), and quantitative drug assay 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
04038917127653Microvette® CB 200 NC18.1325.10018.1325.1002022-11-30
04038917418263Twist cap for Microvette®65.1244.02865.1244.0282022-11-30
04038917418867Adapter sleeve14.121614.12162024-04-26
04038917988278Archiving Cap with filter65.647.32065.647.3202024-02-20
04038917113861UriSet 24 without acid77.578.01077.578.0102022-11-30
04038917927055Sediplus® S 2000 NX90.109290.10922022-11-30
04038917132176S-Monovette®03.1628.10003.1628.1002016-09-16
04038917431705S-Monovette®04.195204.19522019-09-30
04038917522793S-Monovette®04.1954.10004.1954.1002019-09-24
04038917522830S-Monovette®04.1952.10004.1952.1002019-09-24
04038917522878S-Monovette®04.1954.20004.1954.2002019-09-24
04038917522953S-Monovette®04.1953.20004.1953.2002019-09-24
04038917522991S-Monovette®04.1952.20004.1952.2002019-09-24
04038917523318S-Monovette®04.1953.10004.1953.1002019-09-21
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

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