FDA.reportPublic FDA data

ASP MEDICAL

Primary DI
00840216101609
Brand
ASP MEDICAL
Company
Asp Global, LLC
Model
UBT440
Device description
URINE COLLECTION BAG, 4L, LATEX FREE, 1/EA
Published
2022-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840216101606PackageGS120In Commercial Distribution
00840216101609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084021610160610840216101606
00840216101609008402161016098402161016090840216101609

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
080361159
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216108738ASP MEDICALFMT630V2020-10-21
00840216108943ASP MEDICALFMT7002020-10-21
00840216108967ASP MEDICALFMT7102020-10-21
00840216108974ASP MEDICALFMT6552020-10-21
00840216108998ASP MEDICALFMT645V2020-10-21
00840216109018ASP MEDICALFMT640V2020-10-21
00840216109025ASP MEDICALFMT635V2020-10-21
00840216110922ASP MEDICALFMT605HEART2022-02-09
00840216129245PRIMOSC101P-K2026-05-21
00840216129252PRIMOSC201P-K2026-05-21
00840216129269ASP GLOBAL PRIMOAFOVERLAY-B-K2026-05-21
00840216129276ASP GLOBAL PRIMOAFOVERLAY-A-K2026-05-21
00840216120037ASP MEDICAL1038SM-ASP2022-08-08
00840216120044ASP MEDICAL1038LG-ASP2022-08-08
00840216120051ASP MEDICAL1038XL-ASP2022-08-08
00840216120068ASP MEDICAL10382XL-ASP2022-08-08
00840216117600ASP MEDICAL1206BG22022-05-09
00840216118171ASP MEDICAL1207BG22022-05-09
00840216118188ASP MEDICAL1208BG22022-05-09
00840216118195ASP MEDICAL1206BG2B2022-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00610075093458HollisterHOLLISTER INCORPORATEDNNZ2022-12-01
00610075093465HollisterHOLLISTER INCORPORATEDNNZ2022-12-01
20610075093452HollisterHOLLISTER INCORPORATEDNNZ2022-12-01
20610075093469HollisterHOLLISTER INCORPORATEDNNZ2022-12-01
10840216101606ASP MEDICALASP GLOBAL, LLCNNZ2022-04-15
05055788767640Leg Bag Holder Extra LargeFLEXICARE MEDICAL LIMITEDNNZ2020-03-25
05055788767671Leg Bag Holder LargeFLEXICARE MEDICAL LIMITEDNNZ2020-03-25
05055788767701Leg Bag Holder MediumFLEXICARE MEDICAL LIMITEDNNZ2020-03-25
05055788767732Leg Bag Holder SmallFLEXICARE MEDICAL LIMITEDNNZ2020-03-25
00815947020703CURE MEDICALCONVATEC, PURCHASING DEPARTMENTNNZ2016-09-24
20815947020707Cure Medical®CURE MEDICAL LLCNNZ2016-09-24