FDA.reportPublic FDA data

Create Biotech

Primary DI
04719874950651
Brand
Create Biotech
Company
CREATE BIOTECH CO., LTD.
Model
016-009-003
Device description
Headgear
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
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719874950651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719874950651047198749506514719874950651

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia mask strap, single-useA non-sterile, non-latex strap/head harness intended to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and affixed to the mask. It is typically used for anaesthesia of long duration. This is a single-use device.

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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719874957315Create BiotechCB-S350-022026-07-21
04719874950446Create Biotech008-018-20002026-07-21
04719874950637Create Biotech008-021-11802026-07-21
04719874950644Create Biotech016-004-0012026-07-21
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
00848530109875Ventilator accessorySunset Healthcare Solutions, Inc.BZO2026-10-27
04055146499122Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499146Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499467Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499474Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499481Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499498Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499634Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055147001393Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055147001409Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146040935Breathing set, unheatedWILAmed GmbHBZO2026-10-19
04048675826088VentStar Coax GSL 180Drägerwerk AG & Co. KGaABZO2026-10-15
04048675826316Anesthesia Set Coax GSL 180Drägerwerk AG & Co. KGaABZO2026-10-15
05404013001507ClassicPlastiflex GroupBZO2026-09-21
05404013001521ClassicPlastiflex GroupBZO2026-09-21
00848530109813AerosolSunset Healthcare Solutions, Inc.BZO2026-09-09
14026704929204GIBECKTELEFLEX INCORPORATEDBZO2026-08-01
04719874950637Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874950644Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874951139Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874951146Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874957483Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874957919Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959128Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959487Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959494Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959500Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959517Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959524Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
00848530108854Breathing CircuitSunset Healthcare Solutions, Inc.BZO2026-05-12