FDA.reportPublic FDA data

"SPO2 AD CB, PHILIPS 8-PIN NELLC0R OXM,6"""

Primary DI
00840828182003
Brand
"SPO2 AD CB, PHILIPS 8-PIN NELLC0R OXM,6"""
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
CB-A400-0604
Catalog number
26413
Device description
"SPO2 AD CB, PHILIPS 8-PIN NELLC0R OXM,6"""
Published
2020-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182220000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182220000Curbell branded Patient Monitoring CablesCurbell Medical Products, Inc.2018-11-07DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840828182003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828182003008408281820038408281820030840828182003

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

Contacts#

Phone, Email table
PhoneEmail
1-800-235-7500mwinter@curbellmedical.com

Regulatory Flags#

DUNS number
796452311
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840828197021GEN4 INTERACTIVE418430U-0104029309322026-10-15
00840828197038GEN4 INTERACTIVE418430U-0637009309332026-10-15
00840828197052GEN4 INTERACTIVE433383U-0134008309482026-10-15
00840828197069US MATT PAD-UNI-CONNECT-NO LOGOCSP-US-U10-NL309552026-10-15
00840828197076RESPONDER 5, INTERACTIVE5I4125U-162443A309702026-10-15
00840828197083RESPONDER 5, INTERACTIVE5I4128U-101023A309622026-10-15
00840828197090GEN4 INTERACTIVE439331U-0142018309652026-10-15
00840828197106GEN4 DIRECT ACCESSDARPSV-5007309432026-10-15
00840828197113GEN4 INTERACTIVE42521VU-0736018309522026-10-15
00840828197137GEN4 INTERACTIVE4G19TU-0131008310012026-10-15
00840828197144MBA-BE,S37,INL,1'BCC-5801-A01307882026-10-15
00840828197151MBA-BE,S37,INL,6'BCC-5801-A06307892026-10-15
00840828197168MBA-BE,P37,INL,1'BCC-5801-E01307902026-10-15
00840828197175MBA-BE,P37,INL,6'BCC-5801-E06307912026-10-15
00840828197182MBA-WE,P37,INL,1',DPBCC-5802-A01-001307922026-10-15
00840828197199MBA-WE,P37,INL,6',DPBCC-5802-A06-001307932026-10-15
00840828197205MBA-WE,P37(90),1',DPBCC-5803-A01-001307942026-10-15
00840828197212MBA-WE,P37(90),6',DPBCC-5803-A06-001307952026-10-15
00840828197229GEN4 INTERACTIVE4M190E-Z700038310062026-10-15
00840828197236GEN4 INTERACTIVE439430U-0143009310452026-10-15

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