A/OLG-2900A

GUDID 00841983104152

RS-232 to Analog Interface Cable

NIHON KOHDEN AMERICA, INC.

Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor
Primary Device ID00841983104152
NIH Device Record Key663a05a0-cc88-45be-b2bc-12becc00f6c7
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberOLG-2900A
Catalog NumberA/OLG-2900A
Company DUNS021063219
Company NameNIHON KOHDEN AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com
Phone1-800-325-0283
EmailVitalSignsTechSupport@nihonkohden.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841983104152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-06
Device Publish Date2018-10-12

Devices Manufactured by NIHON KOHDEN AMERICA, INC.

10841983103947 - NA2023-10-09 PAPER, ECG1250, 9020, 10 PADS
10841983103954 - NA2023-10-09 PAPER, ECG1350, 9130, 10 PADS
10841983103930 - NA2023-08-17 PAPER, ECG-1550A, 10 PADS
00841983104336 - NK-HealthProtect Wireless Surge Solution2021-12-31 Wireless Surge Solution, field deployable ambulatory monitoring of up to 8 patients with pop-up central monitoring
10841983102667 - NA2021-11-10 SpO2 probe Adults, child (from 15 to 50 kg) Finger, disposable
10841983102674 - NA2021-11-10 SpO2 probe Child, infant (from 3 to 15 kg) Toe, disposable
10841983102704 - BluPRO®2021-11-10 SpO2 probe Adults (30 kg or more) Finger or toe, disposable, 80cm cable
10841983102711 - BluPRO®2021-11-10 SpO2 probe Adults (30 kg or more) Finger or toe, disposable, 160cm cable

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