FDA.reportPublic FDA data

Micro tube 0.5ml K3E

Primary DI
04038917389037
Brand
Micro tube 0.5ml K3E
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
41.1395.102
Catalog number
41.1395.102
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PPMGeneral purpose reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917389020PrimaryGS10
04038917389037Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917389020040389173890204038917389020
04038917389037040389173890374038917389037

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.

Sterilization Methods#

Method table
Method

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
04038917085519S-Monovette®-Needle85.116085.11602016-09-16
04038917086370S-Monovette®-Needle85.137285.13722016-09-16
04038917086387S-Monovette®-Needle85.137385.13732016-09-16
04038917086653S-Monovette®-Needle85.144085.14402016-09-16
04038917086660S-Monovette®-Needle85.144185.14412016-09-16
04038917126021Safety-Needle85.1160.20085.1160.2002016-09-16
04038917126045Safety-Needle85.1162.20085.1162.2002016-09-16
04038917127943Safety-Needle85.1372.20085.1372.2002016-09-16
04038917127950Safety-Needle85.1373.20085.1373.2002016-09-16
04038917129190Safety-Needle85.1440.20085.1440.2002016-09-16
04038917129206Safety-Needle85.1441.20085.1441.2002016-09-16
04038917250474Safety-Needle85.1162.60085.1162.6002016-09-16
04038917530590Safety-Needle 23Gx1"85.1442.20085.1442.2002025-05-02
04038917085526S-Monovette®-Needle85.116285.11622016-09-16
0403891739991310ml TBE 100x16 PP RED SCW CAP51.9923.83051.9923.8302023-01-18
04038917429948Tube 10ml, 100x16mm, PP62.9924.28062.9924.2802023-01-18
04066916044077Tube with cap, 82x13mm60.550.14160.550.1412025-09-26
04038917167918Haemo-Diff®14.121814.12182025-09-25
04038917983259S-Monovette® 1.6ml Serum CAT04.291104.29112025-09-25
04038917983280S-Monovette® 1.6ml Serum CAT04.2911.00104.2911.0012025-09-25

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