FDA.reportPublic FDA data

Create Biotech

Primary DI
04719874953119
Brand
Create Biotech
Company
CREATE BIOTECH CO., LTD.
Model
008-024-017
Device description
Flow Sensor
Published
2026-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BXPTransducer, Gas Flow

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXPTransducer, Gas FlowAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719874953119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719874953119047198749531194719874953119

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit gas-flow sensor, single-useA sterile 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 single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Regulatory Flags#

DUNS number
656387282
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719874950446Create Biotech008-018-20002026-07-21
04719874950637Create Biotech008-021-11802026-07-21
04719874950644Create Biotech016-004-0012026-07-21
04719874950651Create Biotech016-009-0032026-07-21
04719874950675Create Biotech016-002-0032026-07-21
04719874950781Create Biotech002-009-3012026-07-21
04719874950972Create Biotech022-003-1012026-07-21
04719874950989Create Biotech022-004-1012026-07-21
04719874950996Create Biotech022-005-1012026-07-21
04719874951009Create Biotech022-011-1012026-07-21
04719874951023Create Biotech022-009-0012026-07-21
04719874951061Create Biotech023-002-10142026-07-21
04719874951078Create Biotech019-008-0022026-07-21
04719874951085Create Biotech007-002-0002026-07-21
04719874951092Create Biotech007-002-0012026-07-21
04719874951139Create Biotech016-009-0012026-07-21
04719874951146Create Biotech016-009-0022026-07-21
04719874951153Create Biotech016-002-0012026-07-21
04719874951160Create Biotech016-002-0022026-07-21
04719874951177Create Biotech016-002-0042026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874951252Create BiotechCREATE BIOTECH CO., LTD.BXP2026-07-21
04719874952785Create BiotechCREATE BIOTECH CO., LTD.BXP2026-07-21
04719874952792Create BiotechCREATE BIOTECH CO., LTD.BXP2026-07-21
04719874953256Create BiotechCREATE BIOTECH CO., LTD.BXP2026-07-21
04719874953270Create BiotechCREATE BIOTECH CO., LTD.BXP2026-07-21
04719874957384Create BiotechCREATE BIOTECH CO., LTD.BXP2026-07-21
04719874958848Create BiotechCREATE BIOTECH CO., LTD.BXP2026-07-21
00884838105584Flow SensorRespironics Novametrix, LLCBXP2023-11-15
00884838105607Flow SensorRespironics Novametrix, LLCBXP2023-11-15
30884838105585RespironicsRespironics Novametrix, LLCBXP2023-11-15
30884838105608RespironicsRespironics Novametrix, LLCBXP2023-11-15
07640142190479Spiro-SP TrueFlow SensorNDD Medizintechnik AGBXP2023-06-23
20884521210933Puritan BennettCovidien LPBXP2023-02-03
10884521210936Puritan BennettCovidien LPBXP2023-02-03
04048675005612SpiroLifeDrägerwerk AG & Co. KGaABXP2022-04-08
04048675448860Spirolog Flow SensorDrägerwerk AG & Co. KGaABXP2022-04-08
04048675448938Infinity ID Flow SensorDrägerwerk AG & Co. KGaABXP2022-04-08
20884521139852Puritan BennettCovidien LPBXP2021-04-15
10884521139855Puritan BennettCovidien LPBXP2021-04-15
00884838014114Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014121Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014138Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014145Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014152Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014350Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014367Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014374Flow SensorRespironics Novametrix, LLCBXP2020-09-14
06944904096766Respiratory Mech mod,w/accssryShenzhen Mindray Bio-Medical Electronics Co., Ltd.BXP2020-05-07
06420099000554M9256, SpiroSafe Disposable Flow TransducerMedikro OyBXP2018-07-13
06420099000561M9256, SpiroSafe Disposable Flow TransducerMedikro OyBXP2018-07-13