FDA.report

ESR rack for Monovette®

Primary DI
04038917085205
Brand
ESR rack for Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
90.1060
Catalog number
90.1060
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
JPHTEST, ERYTHROCYTE SEDIMENTATION RATE

Product Code Classifications

CodeDeviceSpecialtyClass
JPHTest, Erythrocyte Sedimentation RateHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038917085205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917085205040389170852054038917085205

GMDN Terms

TermDefinition
Erythrocyte sedimentation rate (ESR) rack IVD, scaled measureA dedicated, non-sterile, rack with a build-in graduated scale ruler, with or without a programmable timer or stop-clock, intended to be used to hold erythrocyte sedimentation rate (ESR) tubes containing unmarked columns of blood in an upright and secured position, as required when performing a manual estimation of the ESR of a whole blood clinical specimen. This is a reusable device.

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
true
Serial number
false
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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