prolaio Convenience Kit

Primary DI
00850071330151
Brand
prolaio Convenience Kit
Company
Prolaio, Inc.
Model
H
Device description
prolaio Convenience Kit - Model H
Published
2026-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850071330151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850071330151008500713301518500713301510850071330151

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography monitoring system receiverAn electrically-powered component of an electrocardiograpy telemetric monitoring system designed to wirelessly receive, consolidate, and display electrocardiographic (ECG) signals [sometimes with an additional parameter such as haemoglobin oxygen saturation (SpO2)] from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor).

Contacts#

Phone, Email table
PhoneEmail
855-869-9054support@prolaio.com

Regulatory Flags#

DUNS number
118827870
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850071330168prolaio Convenience KitJ2026-07-24
00850071330052prolaio Heart Rhythm Module1.02026-05-07
00850071330137prolaio Heart Rhythm and Respiration Module2.02026-05-07
00850071330144prolaio eVO2peak Module1.02026-05-07
00850071330007prolaio Mobile AppDP-22-062025-06-13
00850071330014prolaio CloudDP-21-032025-06-13
00850071330038prolaio Personalized Physiology Analytics Engine Software (PPA)1.02025-06-13
00850071330045prolaio Heart Rhythm and Respiration Module3.02025-06-13
00850071330069prolaio Convenience KitD2025-06-13
00850071330076prolaio Convenience KitC2025-06-13
00850071330083prolaio Convenience KitF2025-06-13
00850071330090prolaio Convenience KitB2025-06-13
00850071330106prolaio Convenience KitA2025-06-13
00850071330113prolaio Convenience KitE2025-06-13
00850071330120prolaio Convenience KitG2025-06-13