FDA.reportPublic FDA data

ASP MEDICAL

Primary DI
10840216101606
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080361159
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840216119444ASP MEDICAL1210BG22022-05-09
00840216105423ASP MEDICALRGPA6102022-09-19
00840216102705ASP MEDICALRGPA610SL2022-08-23
00840216102644ASP MEDICALHIA1022022-08-15
00840216106659ASP MEDICALHIA4112022-08-15
00840216119291ASP MEDICALINFHW-ASP2022-08-15
00840216119505ASP MEDICALINFHWD-ASP2022-08-15
00840216101821ASP MEDICALIWA012022-07-22

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
00840216101609ASP 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