FDA.reportPublic FDA data

S-Monovette®

Primary DI
04038917133241
Brand
S-Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
02.1726.022
Catalog number
02.1726.022
Device description
S-Monovette® 9ml
Published
2016-12-06
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
04038917133241PrimaryGS10
04038917205443Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917133241040389171332414038917133241
04038917205443040389172054434038917205443

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated blood collection tube IVD, no additiveA non-evacuated glass or plastic tube, sealed with a stopper, containing no additive and intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. 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
100
DM exempt
true
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
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
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
04038917083492Push cap, neutral65.69765.6972022-11-30

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