FDA.report

Sediplus® S 200, 12 V DC

Primary DI
04038917226431
Brand
Sediplus® S 200, 12 V DC
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
90.189.900
Catalog number
90.189.900
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
false

Related Records

Contact Domains

Product Codes

CodeName
GKBDEVICE, AUTOMATED SEDIMENTATION RATE

Product Code Classifications

CodeDeviceSpecialtyClass
GKBDevice, Automated Sedimentation RateHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038917226431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917226431040389172264314038917226431

GMDN Terms

TermDefinition
Erthrocyte sedimentation rate (ESR) analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used to determine the erythrocyte sedimentation rate (ESR) of red blood cells in an anticoagulated whole blood specimen.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags

DUNS number
388000270
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04038917429948Tube 10ml, 100x16mm, PP62.9924.28062.9924.2802023-01-18
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