FDA.reportPublic FDA data

SPACELABS HEALTHCARE

Primary DI
10841522122811
Brand
SPACELABS HEALTHCARE
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
700900V
Catalog number
376-0561-01
Device description
PEDIATRIC FLOW SENSOR SINGLE ITEM KIT
Published
2017-11-14
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
false

Product Codes#

Code, Name table
CodeName
CBKVENTILATOR, CONTINUOUS, FACILITY USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841522122811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084152212281110841522122811

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit gas-flow sensor, reusableA device that includes a transducer intended to detect the movement of gases in a breathing circuit, and convert this into an electrical signal for relay to a ventilator (e.g., adult/paediatric/neonatal ventilators, anaesthesia system ventilators). It is connected to the breathing circuit and an appropriate data transfer cable and intended to enable the ventilator to display/monitor the gas flow to and from the patient, whereby controlled adjustments may be made. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
145581588
Device count
1
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841522106712Spacelabs HealthcareDATUM130112182017-01-03
10841522131639Eclipse MiniEclipse Mini98900-UK2025-09-29
10841522131417Spacelabs HealthcarePatient cables & ECG leadwires700-0328-012025-09-03
10841522131424Spacelabs HealthcarePatient cables & ECG leadwires700-0330-012025-09-03
10841522129599SpacelabsABP Cuffs and Cuff Covers015-0068-07Q2025-03-13
10841522130816TrulinkNIBP Hoses and Adapters714-0060-022025-03-13
10841522131431OnTrakOnTrak90227-82025-02-27
10841522100406Spacelabs HealthcareAbsorber122009022016-12-29
10841522100413Spacelabs HealthcareAbsorber122009032016-12-29
10841522100383Spacelabs HealthcareAbsorber122009002016-12-29
10841522100390Spacelabs HealthcareAbsorber122009012016-12-29
10841522100420Spacelabs HealthcareAbsorber122009042016-12-29
10841522100437Spacelabs HealthcareAbsorber122009052016-12-29
10841522131455QubeQube Compact Monitor913902024-12-04
10841522131462qube miniQube Mini913892024-12-04
10841522131479XprezzonXprezzon Monitor913932024-12-04
10841522129216SpacelabsSmart Alarm Interface (SAI)961812024-08-16
30841522126417TrulinkNIBP Hoses and adapters704-00272024-07-16
10841522129773Lifescreen ProLifescreen Pro040-5173-002024-07-16
30841522125618Spacelabs HealthcarePatient cables & ECG leadwires50-00492018-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850057117370RESPOND VentilatorCORVENT MEDICAL, INCCBK2026-01-06
00850057117387Flow SensorCORVENT MEDICAL, INCCBK2026-01-06
00850057117394RESPOND Exhalation ManifoldCORVENT MEDICAL, INCCBK2026-01-06
00850057117400Exhalation ValveCORVENT MEDICAL, INCCBK2026-01-06
00850057117417RESPOND HME Patient Circuit Kit (Tubing, Connector & HME/CORVENT MEDICAL, INCCBK2026-01-06
00850057117424HEPA FiltersCORVENT MEDICAL, INCCBK2026-01-06
00850057117448Green Oxygen Hose, 8ftCORVENT MEDICAL, INCCBK2026-01-06
00850057117455Oxygen Tubing with Connector, 7ftCORVENT MEDICAL, INCCBK2026-01-06
00850057117462Cart, IV Power StripCORVENT MEDICAL, INCCBK2026-01-06
00850057117479Cart, IV Power Strip MountCORVENT MEDICAL, INCCBK2026-01-06
00850057117486Patient Circuit Arm ClipCORVENT MEDICAL, INCCBK2026-01-06
00850070543033Emergency Ventilator Complete PackageVentis Medical Inc.CBK2025-12-31
00853678006733pNeuton Model A with 6ft Patient CircuitAIRON CORPORATIONCBK2025-12-19
20197344102652MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102669MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102676MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102683MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102690MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102706MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477507F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477514F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477521F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480453F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CBK2025-12-02
06903053046022VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.CBK2025-11-29
06903053046060VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.CBK2025-11-29
10190752190535LTVVYAIRE MEDICAL, INC.CBK2025-08-26
00850018761413Internal Battery PM Upgrade USB DriveVENTEC LIFE SYSTEMS, INC.CBK2025-08-06