FDA.reportPublic FDA data

NA

Primary DI
14931921829445
Brand
NA
Company
NIHON KOHDEN CORPORATION
Model
TL-062S
Catalog number
TL-062S
Device description
SpO2 probe Child, infant (from 3 to 15 kg) Toe, disposable
Published
2016-09-05
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLVStandard polysomnograph with electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14931921829445PrimaryGS10
04931921829448Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1493192182944514931921829445
04931921829448049319218294484931921829448

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, single-useA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). The is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)325-0283info@nkusa.com

Regulatory Flags#

DUNS number
690568050
Device count
5
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04931921877401BluPRO®TL-601T0P3112026-02-03
04931921044353cap-ONE`YG-211TYG-211T-A12024-06-21
04931921017524NAZR-920PZR-920P-FT2024-01-25
04931921017159CNS-2101 Central MonitorCNS-2101CNS-21012023-10-30
04931921007723Nihon Kohden, EEG-1200A Series NeurofaxKD-029A-01KD-029A-012019-07-24
04931921007730Nihon Kohden, EEG-1200A Series NeurofaxKE-122A-01KE-122A-012019-07-24
04931921017166CNS-2101 Central MonitorCNS-2101CNS-21012023-10-01
04931921010235cap-ONEYG-220TYG-220T2023-05-22
04931921010273cap-ONEYG-221TYG-221T2023-05-22
04931921010303cap-ONEYG-230TYG-230T2023-05-22
04931921010334cap-ONEYG-231TYG-231T2023-05-22
04931921007631Nihon Kohden, EEG-1200A Series NeurofaxJE-921A-01JE-921A-012019-07-24
04931921007709Nihon Kohden, EEG-1200A Series NeurofaxLS-703A-01LS-703A-012019-07-24
04931921007716Nihon Kohden, EEG-1200A Series NeurofaxLS-706A-01LS-706A-012019-07-24
04931921025727cap-ONETG-980P1TG-980P12022-05-12
04931921005828BluPRO®TL-271T3TL-271T3-A242022-04-06
04931921000045Smart Cable NMT Module and AccessoriesDH-101PDH-101P2021-09-27
04931921002018Nihon Kohden Life Scope G5 Bedside Monitoring SystemCU-151RCU-151R2021-09-27
04931921002056Nihon Kohden Life Scope G5 Bedside Monitoring SystemCU-152RCU-152R2021-09-27
04931921002087N/AAA-174PAA-174P2021-09-27

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