FDA.reportPublic FDA data

Dolphin

Primary DI
00859998006200
Brand
Dolphin
Company
OSI OPTOELECTRONICS, INC.
Model
3314-C
Device description
Neonatal / Adult Disposable Oximetry Sensor
Published
2016-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030952000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030952000DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421Dolphin Medical, Inc.2003-05-19DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859998006200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859998006200008599980062008599980062000859998006200

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
612770974
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859998006439TruLink015-0660-0021-008162021-02-24
00859998006446TruLink015-0661-0021-008172021-02-24
00859998006453TruLink015-0667-0021-008092021-02-24
00859998006460TruLink015-0666-0021-008102021-02-24
00859998006477TruLink015-0664-0021-008112021-02-24
00859998006484TruLink015-0665-0021-008122021-02-24
00859998006491TruLink015-0662-0021-008132021-02-24
00859998006507TruLink015-0663-0021-08142021-02-24
00859998006347BluSat42412021-02-02
00859998006354BluSat12932021-02-02
00859998006378BluSat40422021-02-02
10859998006306BluSat43412021-02-02
10859998006313BluSat43422021-02-02
10859998006320BluSat43432021-02-02
10859998006337BluSat43442021-02-02
30859998006300BluSat43412021-02-02
30859998006317BluSat43422021-02-02
30859998006324BluSat43432021-02-02
30859998006331BluSat43442021-02-02
00859998006361BluSat40412020-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410746CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09