FDA.reportPublic FDA data

Leg Bag Holder Medium

Primary DI
05055788767701
Brand
Leg Bag Holder Medium
Company
FLEXICARE MEDICAL LIMITED
Model
00-0036U
Published
2020-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05055788767701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055788767701050557887677015055788767701

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, reusableA patient-worn, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
504406273
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055788767640Leg Bag Holder Extra Large00-0038U2020-03-25
05055788767671Leg Bag Holder Large00-0037U2020-03-25
05055788767732Leg Bag Holder Small00-0035U2020-03-25
05055788787044Flexicare040-11-0000U2026-03-31
05055788787068Flexicare040-12-0130U2026-03-31
05055788787082Flexicare040-12-0140U2026-03-31
05055788787105Flexicare040-12-2130U2026-03-31
05055788787129Flexicare040-12-2135U2026-03-31
05055788787143Flexicare040-12-2140U2026-03-31
05055788791317Flexicare030-620/1U2024-03-13
05055931101963Maxineb Duo Filter Pad032-10-021U2020-03-27
05055931101970Maxineb Duo032-10-031U2020-03-27
05055931101994Maxineb Duo Nebulizer + Mouthpiece032-10-033U2020-03-27
05055931102014Maxineb Duo Nebulizer + Mouthpiece And Filter032-10-034U2020-03-27
05055931102038Maxineb Duo Filter032-10-035U2020-03-27
05055931102052Maxineb Duo Filter Master Case032-10-036U2020-03-27
05055931102076Maxineb Duo Nebulizer And Tubing032-10-037U2020-03-27
05055931102090Maxineb Duo Nebulizer + Mouthpiece And Tubing032-10-038U2020-03-27
05055931102113Maxineb Duo Nebulizer + Mouthpiece, Tubing And Filter032-10-039U2020-03-27
05055931102120Maxineb Duo Triggered Nebulizer W/ Adult Aerosol Mask And Tubing032-10-045U2020-03-27

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
10840216101606ASP MEDICALASP GLOBAL, LLCNNZ2022-04-15
05055788767640Leg Bag Holder Extra LargeFLEXICARE MEDICAL LIMITEDNNZ2020-03-25
05055788767671Leg Bag Holder LargeFLEXICARE 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