FDA.report

S-Monovette®

Primary DI
04038917025652
Brand
S-Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
04.1920.100
Catalog number
04.1920.100
Device description
S-Monovette® 4ml 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

Related Records

Contact Domains

Product Codes

CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications

CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038917025652PackageGS1500In Commercial Distribution
04038917134378PrimaryGS10
04038917206983Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917025652040389170256524038917025652
04038917134378040389171343784038917134378
04038917206983040389172069834038917206983

GMDN Terms

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

Contacts

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

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