FDA.reportPublic FDA data

S-Monovette®

Primary DI
04038917228305
Brand
S-Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
01.1624.001
Catalog number
01.1624.001
Device description
S-Monovette® 8.8 ml ACD-A
Published
2016-09-22
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0700290

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0700290

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917228299PackageGS1500Not in Commercial Distribution
04038917228305PrimaryGS10
04038917228312Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917228299040389172282994038917228299
04038917228305040389172283054038917228305
04038917228312040389172283124038917228312

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated blood collection tube IVD, anticoagulantA non-evacuated glass or plastic tube, sealed with a stopper, containing an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), lithium heparin, sodium citrate]. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., blood lead, whole blood haematology such as complete blood count (CBC), molecular diagnostics, and immunohaematology testing (ABO grouping, Rh typing, antibody screening, plasma coagulation studies and/or and quantitative drug assay determinations)]. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
388000270
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038917133203S-Monovette®02.1726.00102.1726.0012016-09-16
04038917133326S-Monovette®01.1728.00101.1728.0012016-09-16
04038917133371S-Monovette®05.1729.00105.1729.0012016-09-16
04038917134422S-Monovette®04.1926.00104.1926.0012016-09-16
04038917240895S-Monovette®05.172905.17292016-09-16
04038917567244S-Monovette®06.165906.16592020-08-17
04038917982429S-Monovette® 2.7ml05.1729.02105.1729.0212023-11-03
04038917133234S-Monovette®02.1726.02102.1726.0212017-02-08
04038917133241S-Monovette®02.1726.02202.1726.0222016-12-06
04038917085359Membrane-Adapter14.111214.11122016-09-16
04038917085793Multi-Adapter14.120514.12052016-09-16
04038917126663Multi-Adapter14.1205.05014.1205.0502016-09-16
04038917126700Multi-Adapter14.1205.10014.1205.1002016-09-16
04038917354776Blood Culture Adapter14.120914.12092016-09-16
04038917364188Blood Culture Adapter LongNeck14.120714.12072024-04-26
04066916046057PCMT 2ML ATC SAF BR 240/BG72.695.05172.695.0512026-10-14
04038917994224Micro tube 0.5ml, PP72.730.30572.730.3052024-09-23
04038917112529tube with screw cap 7ml, 82x13mm, PP60.550.04960.550.0492023-07-22
04038917413008tube with srew cap 5ml, 75x13mm, PP62.504.03962.504.0392023-07-22
04038917080873Push cap, neutral65.10965.1092022-11-30

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