FDA.reportPublic FDA data

S-Monovette®

Primary DI
04038917567244
Brand
S-Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
06.1659
Catalog number
06.1659
Device description
S-Monovette® 1.1ml
Published
2020-08-17
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
04038917567244PrimaryGS10
04038917567251Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917567244040389175672444038917567244
04038917567251040389175672514038917567251

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
50
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
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
04038917083492Push cap, neutral65.69765.6972022-11-30

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