FDA.reportPublic FDA data

BCI

Primary DI
10610586039669
Brand
BCI
Company
ICU MEDICAL, INC.
Model
WW1018R
Published
2020-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DPZOximeter, ear
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPZOximeter, EarCardiovascular2
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083557000
K083705000
K083787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083557000BCI WW1030 PULSE OXIMETERSmiths Medical Pm, Inc.2009-05-01DQA
K083705000BCI WW1020 PULSE OXIMETER, MODEL WW1020Smiths Medical Pm, Inc.2009-04-09DQA
K083787000BCI WW1000 PULSE OXIMETER, MODEL WW1000Smiths Medical Pm, Inc.2009-04-15DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10610586039669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061058603966910610586039669

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, line-poweredA mains electricity (AC-powered) photoelectric device intended for the continuous transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically used bedside.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709197272BivonaFT26FN70NSZ233N2026-07-23
10887709198392BivonaSU26GN80NZC083N2026-07-23
10887709198408BivonaZA26GN85NSC085N2026-07-23
10887709198750BivonaSZ26GN70ZSZ114N2026-07-23
10887709198873BivonaZU26GN75NSC099N2026-07-23
10887709198941BivonaZU26GN60NGF143N2026-07-23
10887709198958BivonaZU26GN55NGF144N2026-07-23
10887709199085BivonaFU26GN35NGF169N2026-07-23
10887709199092BivonaFT26GN35NGA089N2026-07-23
10887709199108BivonaFT26GN35NGE166N2026-07-23
10887709199115BivonaST26GN40NGF165N2026-07-23
10887709199146BivonaFT26GN55NGC172N2026-07-23
10887709199153BivonaFU26GN55NGC170N2026-07-23
10887709199160BivonaFT26GN50NGC171N2026-07-23
10887709199177BivonaFU26GN40NGA178N2026-07-23
10887709199184BivonaFU26GN55NSF173N2026-07-23
10887709199207BivonaST26GN50NSC177N2026-07-23
10887709199214BivonaFT26GN30NGF174N2026-07-23
10887709199221BivonaST26GN55NSC176N2026-07-23
10887709199238BivonaFT26GN40NGE175N2026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
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
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400785CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410326CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410333CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410340CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410364CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410371CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410388CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410395CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410401CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410418CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410425CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410432CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410449CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410456CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410647CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410678CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410685CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410692CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410715CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410722CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410739CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09