FDA.report

Premier

Primary DI
20610075188677
Brand
Premier
Company
HOLLISTER INCORPORATED
Model
84890
Catalog number
84890
Device description
1-Piece Urostomy Pouch, Convex, Flextend
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EXGBAG, URINE COLLECTING, URETEROSTOMY

Product Code Classifications

CodeDeviceSpecialtyClass
EXGBag, Urine Collecting, UreterostomyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20610075188677PackageGS124In Commercial Distribution
00610075188673PrimaryGS10
00610075082612Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007518867720610075188677
00610075188673006100751886736100751886730610075188673
00610075082612006100750826126100750826120610075082612

GMDN Terms

TermDefinition
One-piece urostomy bag, open-endedA one-piece plastic pouch designed to be attached with adhesive to a patient's skin around a stoma for use as a urine collection device in the management of urinary diversions; it includes a drainage tap to permit the emptying of fluids (open-ended). The entire device is removed when changed. This is a single-use device.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter13Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)323-4060cs@hollister.com

Regulatory Flags

DUNS number
005527098
Device count
5
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
false
No natural rubber latex
true
Sterilization required before use
false

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