FDA.reportPublic FDA data

S-Monovette®

Primary DI
04038917031912
Brand
S-Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
05.1553.100
Catalog number
05.1553.100
Device description
S-Monovette® 2.7ml 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
04038917031912PackageGS1500In Commercial Distribution
04038917130431PrimaryGS10
04038917203210Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917031912040389170319124038917031912
04038917130431040389171304314038917130431
04038917203210040389172032104038917203210

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
04038917968560SAHARA-TSC 115V97.8710.60297.8710.6022023-11-24
04038917080873Push cap, neutral65.10965.1092022-11-30
04038917081306Tube 10ml, 95x16.8mm, K3E26.35826.3582022-11-30
04038917081344Tube 10ml, 95x16.8mm, LH26.36926.3692022-11-30
04038917082952Faeces tube 75x23.5mm80.62080.6202022-11-30
04038917082969Faeces tube 75x23.5mm80.62180.6212022-11-30
04038917083096Sample cup 3.5ml, PS73.64673.6462022-11-30
04038917083195Sample cup 2ml for ES300/60073.66373.6632022-11-30
04038917083232Sample cup for AXSYM73.66773.6672022-11-30
04038917083409Micro tube 1.5ml, PP72.68872.6882022-11-30
04038917083416Micro tube 2ml, PP72.68972.6892022-11-30
04038917083508Micro tube 0.5ml, PP72.69872.6982022-11-30
04038917083713Push cap, neutral65.72365.7232022-11-30
04038917083959Round cuvette, PP68.75268.7522022-11-30
0403891708484096 PCR Plate Biosphere® Plus72.98572.9852022-11-30
04038917085595Transfer pipette 3.5ml86.117386.11732023-01-12
04038917085618Transfer pipette 6ml86.117586.11752023-01-12
04038917085632Transfer pipette 1ml86.117986.11792023-01-12
04038917109710Tube 5ml, 75x12mm, PP, MF55.526.05355.526.0532022-11-30
04038917111713Tube 30ml, 107x25mm, PP62.543.03062.543.0302022-11-30

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