FDA.report

Monovette®

Primary DI
04038917280662
Brand
Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
05.1147.028
Catalog number
05.1147.028
Device description
Monovette® 2ml LH blood gas
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
04038917280662PackageGS1500In Commercial Distribution
04038917280679PrimaryGS10
04038917280686Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917280662040389172806624038917280662
04038917280679040389172806794038917280679
04038917280686040389172806864038917280686

GMDN Terms

TermDefinition
Blood gas syringe IVD, lithium heparinA sterile glass or plastic syringe, without a pre-attached needle, containing the anticoagulant lithium heparin intended to be used for the collection, and preservation and/or transport, of blood for blood gas determination and/or other investigation. 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
100
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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04038917983372S-Monovette® 1.6ml LH04.291304.29132025-09-25
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