Create Biotech

Primary DI
04719874957391
Brand
Create Biotech
Company
CREATE BIOTECH CO., LTD.
Model
021-002-2000
Device description
Drainage Bag
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
NNWBag, Urine Collection, Leg, For External Use, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNWBag, Urine Collection, Leg, For External Use, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719874957391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719874957391047198749573914719874957391

GMDN Terms#

Term, Definition table
TermDefinition
Non-wearable adult urine collection bag, open-endedA flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. 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

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