FDA.reportPublic FDA data

Create Biotech

Primary DI
04719874957568
Brand
Create Biotech
Company
CREATE BIOTECH CO., LTD.
Model
021-004-0360-1
Device description
Yankauer Suction
Published
2026-07-16
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
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719874957568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719874957568047198749575684719874957568

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). 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
04719874951467Create Biotech003-009-0012026-07-16
04719874951504Create Biotech005-001-0302026-07-16
04719874954611Create Biotech015-111-0122026-07-16
04719874955939Create Biotech003-011-0012026-07-16
04719874956547Create Biotech010-001-10642026-07-16
04719874956554Create Biotech010-001-10652026-07-16
04719874957575Create Biotech008-016-10502026-07-16
04719874957667Create Biotech021-005-0082026-07-16
04719874958459Create Biotech021-008-0082026-07-16
04719874958503Create Biotech021-004-02002026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874958503Create BiotechCREATE BIOTECH CO., LTD.JOL2026-07-16
00190776396794MillenniumAvalign Technologies, Inc.JOL2026-07-14
00888937033823ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033830ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033847ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033854ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033861ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00848530109110Suction KitSUNSET HEALTHCARE SOLUTIONS, INC.JOL2026-06-10
10192253038927ArgyleCardinal Health 200, LLCJOL2026-05-07
10080196994137MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-27
10080196035458MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-02
10080196995561MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-02
10080196035434MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-16
10080196995554MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-13
10192253039665CARDINAL HEALTHCardinal Health 200, LLCJOL2025-12-16
07613327680720Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
00840183530990BR Surgical, LLCBR Surgical, LLCJOL2025-09-05
10197344153671MEDLINEMEDLINE INDUSTRIES, INC.JOL2025-05-21
10192253041866ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253041873ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253041880ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253038941ArgyleCardinal Health 200, LLCJOL2025-02-28
10192253038958ArgyleCardinal Health 200, LLCJOL2025-02-28
10192253039672ArgyleCardinal Health 200, LLCJOL2024-12-04
10192253003628ArgyleCardinal Health 200, LLCJOL2024-10-09
10192253002928ArgyleCardinal Health 200, LLCJOL2024-09-27
10192253002935ArgyleCardinal Health 200, LLCJOL2024-09-27