FDA.report

EncorePro 2, Software

Primary DI
00606959050778
Brand
EncorePro 2, Software
Company
Respironics, Inc.
Model
2.22
Catalog number
1054785
Device description
EncorePro 2, Software
Published
2018-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MNSVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Product Code Classifications

CodeDeviceSpecialtyClass
MNSVentilator, Continuous, Non-Life-SupportingAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00606959050778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00606959050778006069590507786069590507780606959050778

GMDN Terms

TermDefinition
Medical equipment clinical data interfacing softwareAn application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags

DUNS number
080728314
Device count
1
DM exempt
false
Premarket exempt
false
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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