FDA.reportPublic FDA data

Pulse Oximeter

Primary DI
00786511086404
Brand
Pulse Oximeter
Company
RASHMAN CORPORATION
Model
SB456-PUR
Device description
SB BASIC PULSE OXIMETER-PUR-BX
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082641000FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DLContec Medical System Co., Ltd.2008-11-10DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00786511086404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00786511086404007865110864047865110864040786511086404

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reprocessedA 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, produced by a light-emitting diode (LED) and a receiving detector, are received by an oximeter to which this device is connected. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078803608
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00786511077938StethoscopeS121-AQS2022-12-06
00786511249236StethoscopeS120-BLK2022-12-06
00786511249243StethoscopeS120-ROY2022-12-06
00786511249250StethoscopeS120-PUR2022-12-06
00786511249267StethoscopeS120-SAS2022-12-06
00786511462192StethoscopeS108-HPK2022-12-06
00786511559113StethoscopeS108-STE2022-12-06
00786511563851StethoscopeS121-BLK2022-12-06
00786511566463StethoscopeS108-P-HPK2022-12-06
00786511566470StethoscopeS108-I-HPK2022-12-06
00786511566913StethoscopeS108-CBL2022-12-06
00786511624958StethoscopeS108-P-BLK2022-12-06
00786511629106StethoscopeS108-I-BLK2022-12-06
00786511629113StethoscopeS108-BLK2022-12-06
00786511629274StethoscopeS106-BLK2022-12-06
00786511769116StethoscopeS108-NAV2022-12-06
00786511869113StethoscopeS108-ROY2022-12-06
00786511879112StethoscopeS108-TEA2022-12-06
00786511939113StethoscopeS108-PUR2022-12-06
00786511077839StethoscopeS126-AQS2022-12-05

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Primary DI, Brand, Company table
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06920485308450BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DQA2026-06-01
10884521855397NellcorCovidien LPDQA2026-05-29
10884521855403NellcorCovidien LPDQA2026-05-29
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B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
09551028900069Cables and SensorsXINMED SDN. BHD.DQA2026-04-22
06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-04-22
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03