FDA.reportPublic FDA data

Create Biotech

Primary DI
04719874957452
Brand
Create Biotech
Company
CREATE BIOTECH CO., LTD.
Model
008-030-3070
Device description
Nesopharyngeal Airway
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
BTQAirway, Nasopharyngeal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTQAirway, NasopharyngealAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719874957452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719874957452047198749574524719874957452

GMDN Terms#

Term, Definition table
TermDefinition
Nasopharyngeal airway, single-useA rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency. The proximal end of the device may have an integral 22 mm connector for oxygen delivery. 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
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
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00612479273313McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273337McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273351McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273375McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273399McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273412McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273436McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00810094576639CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576646CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576653CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576660CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576677CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576684CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576691CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576707CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576714CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576721CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576738CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576745CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576752CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810003751034KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751041KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751058KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751065KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751072KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751089KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751096KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14