FDA.reportPublic FDA data

Microvette® CB 200 NC

Primary DI
04038917201360
Brand
Microvette® CB 200 NC
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
18.1325.100
Catalog number
18.1325.100
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
GHCTube, Sedimentation Rate
GIOTUBE, COLLECTION, CAPILLARY BLOOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHCTube, Sedimentation RateHematology1
GIOTube, Collection, Capillary BloodHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917127653PrimaryGS10
04038917201360Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917127653040389171276534038917127653
04038917201360040389172013604038917201360

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated erythrocyte sedimentation rate (ESR) tube IVDAn open-ended glass or plastic tube, or other dedicated vessel, intended to be used alone or in combination with other IVDs (e.g., ESR analyser, scaled ruler) for the quantitative determination of the erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen. 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
04066916053802Tube 3.5ml, 92x13 (round), PP62.617.00162.617.0012026-07-21
04038917084093Push cap, neutral65.78265.7822022-11-30
04038917112963Tube 15ml, 120x17mm, PS62.553.04162.553.0412023-11-07
04038917112970Tube 15ml, 120x17mm, PS62.553.04262.553.0422023-11-07
04038917113007Tube 15ml, 120x17mm, PS62.553.54262.553.5422023-11-07
04038917113571Tube 50ml, 115x28mm, PP62.559.01062.559.0102024-10-07
04038917150880Tube 5ml 50x16PS +Cap NAT63.9921.53563.9921.5352023-01-18
04038917151139Tube 10ml 97x16PS+Cap60.9921.83060.9921.8302023-01-18
04038917151528Tube 25ml 90x25PP+Cap60.9922.24360.9922.2432023-01-18
04038917151573Tube 25ml 90x25PP+Cap63.9922.25463.9922.2542023-01-18
04038917155120Tube 10ml, 100x16mm, PP62.9924.27262.9924.2722023-01-18
04038917155137Tube 10ml, 100x16, PP62.9924.27362.9924.2732023-01-18
04038917155144Tube 10ml, 100x16, PP62.9924.27462.9924.2742023-01-18
04038917155182Tube 10ml 100x16PP+Cap62.9924.28362.9924.2832023-01-18
04038917155199Tube 10ml, 100x16mm, PP62.9924.28462.9924.2842023-01-18
04038917155472Set of 4 Tube 12ml 99x16mm60.9924.95260.9924.9522023-01-18
04038917238649Tube 25ml 90x25PP+ Cap63.9922.24863.9922.2482023-01-19
04038917242561Tube 50ml, 114x28mm, PP62.547.27462.547.2742024-10-16
04038917253468Tube 25ml 90x25PP+ Cap60.9922.26060.9922.2602023-01-18
04038917260008Tube 5 ml, 75 x 13 mm , PP55.525.06055.525.0602024-10-24

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Primary DI, Brand, Company table
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00848530108113DIATUBE002Sunset Healthcare Solutions, Inc.GIO2025-12-23
10848530108110DIATUBE002SUNSET HEALTHCARE SOLUTIONS, INC.GIO2025-12-23
00381934774015PTS Diagnostics Capillary TubesPOLYMER TECHNOLOGY SYSTEMS, INC.GIO2025-06-16
10381934774012PTS Diagnostics Capillary TubesPOLYMER TECHNOLOGY SYSTEMS, INC.GIO2025-06-16
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06974621793303LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793310LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
06974621793327LT Kit for PRPZhuhai Longtime Biological Technology Co., LtdGIO2025-06-06
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00850059420447MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2025-02-05
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00850059420461MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2025-02-05
00850059420478MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2025-02-05
00850059420485MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2025-02-05
07350040790687Micro pipette, plastic EDTABoule Medical ABGIO2024-10-04
05700699428981SAFE CLINITUBES D957P-70-70X1Radiometer Medical ApSGIO2024-07-01
04066916001865Microvette® 200 ZSarstedt Aktiengesellschaft & Co.KGGIO2024-06-11
00850059420003SAFECAPDRUMMOND SCIENTIFIC COMPANYGIO2024-05-17
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