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epoc NXS Host

FDA UDI

Class I (US FDA UDI)

by Epocal Inc

Identity

Trade Name
epoc NXS Host FDA UDI
Generic Name
Metabolic profile clinical chemistry analyser IVD FDA UDI
Device Name
The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratoryor at the point of care in hospitals, nursing homes or other clinical care institutions. FDA UDI
Model / Reference
11413475 FDA UDI
Description
The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratoryor at the point of care in hospitals, nursing homes or other clinical care institutions. FDA UDI

Identifiers

Catalog Number
16266 FDA UDI
Primary DI / UDI-DI
00630414606095 FDA UDI
510(k) Number
K200107 FDA UDI
FDA Product Code
KHP FDA UDI
CEM FDA UDI
CGZ FDA UDI
JGS FDA UDI
JFP FDA UDI
CHL FDA UDI
JFL FDA UDI
CGA FDA UDI
GMDN Term
Metabolic profile clinical chemistry analyser IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1450 FDA UDI
862.1600 FDA UDI
862.1170 FDA UDI
862.1665 FDA UDI
862.1145 FDA UDI
862.1120 FDA UDI
862.1160 FDA UDI
862.1345 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Metabolic profile clinical chemistry analyser IVD

epoc NXS Host by Epocal Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metabolic profile clinical chemistry analyser IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epocal Inc

Sources (1)

  • FDA UDI 077a07f6-60de-462a-9ee1-21d1c23d2750 37 fields · synced Jun 6, 2026