FDA.reportPublic FDA data

Dover

Primary DI
10884521025691
Brand
Dover
Company
Cardinal Health, Inc.
Model
8101
Catalog number
8101
Device description
Urine Meter Drainage Bag
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNXCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521025698PackageGS110Not in Commercial Distribution
10884521025691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452102569820884521025698
1088452102569110884521025691

GMDN Terms#

Term, Definition table
TermDefinition
Urine flowmeter, single-useA non-electrical device that is used to measure the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder. This device is a single-use device. This GMDN code may reflect old technology.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2000Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Regulatory Flags#

DUNS number
080935429
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
10884521190948Kangaroo384500W384500W2017-09-12
10884521190894Kangaroo3844003844002017-08-02
10884521544475Wings67093670932018-06-27
20884521544489Wings67095670952018-06-27
10884521023284Monoject8507SA8507SA2016-09-24
10884521208742Devon31145892311458922018-06-29
20884521154244Monoject8985PG2Y8985PG2Y2017-01-06
20884521513423Kendall8618RC8618RC2017-05-27
20884521706177Kangaroo388105E388105E2017-04-20
20884527016034Devon31145926311459262018-06-29
30884521022533Monoject8997SPG28997SPG22016-09-24
30884521022557Monoject8998SPG28998SPG22016-09-24
30884527016048Devon31145942311459422018-06-29
40884521022417Monoject8932PG28932PG22016-09-24
10884521019119SharpSafety8556H8556H2018-06-27
20884527000125Argyle888825737888882573782016-09-24
20884527000132Argyle888825738688882573862016-09-24
10884527019854Argyle888850103188885010312016-09-24
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253071108DoverCardinal Health 200, LLCKNX2026-06-24
10192253071139DoverCardinal Health 200, LLCKNX2026-06-24
10192253071146DoverCardinal Health 200, LLCKNX2026-06-24
10192253068603DoverCardinal Health 200, LLCKNX2026-01-16
10192253068719DoverCardinal Health 200, LLCKNX2026-01-16
10192253068726DoverCardinal Health 200, LLCKNX2026-01-16
10192253068733DoverCardinal Health 200, LLCKNX2026-01-16
10192253067989DoverCardinal Health 200, LLCKNX2026-01-15
10192253068016DoverCardinal Health 200, LLCKNX2026-01-15
10192253068214DoverCardinal Health 200, LLCKNX2026-01-15
10840330701799ProCureTwin Med, LLCKNX2025-05-31
10840330701805ProCureTwin Med, LLCKNX2025-05-31
10192253027792DoverCardinal Health 200, LLCKNX2025-04-01
10192253028232DoverCardinal Health 200, LLCKNX2025-04-01
10192253032161DoverCardinal Health 200, LLCKNX2025-04-01
20192253030058DoverCardinal Health 200, LLCKNX2025-04-01
10192253027945DoverCardinal Health 200, LLCKNX2025-03-20
10192253028461DoverCardinal Health 200, LLCKNX2024-12-20
10192253028522DoverCardinal Health 200, LLCKNX2024-12-20
10192253028539DoverCardinal Health 200, LLCKNX2024-12-20
10192253028546DoverCardinal Health 200, LLCKNX2024-12-20
10192253028560DoverCardinal Health 200, LLCKNX2024-12-20
10192253031126DoverCardinal Health 200, LLCKNX2024-12-20
10192253027938DoverCardinal Health 200, LLCKNX2024-11-04
10192253028287DoverCardinal Health 200, LLCKNX2024-11-04
10192253028492DoverCardinal Health 200, LLCKNX2024-11-04
10192253031447DoverCardinal Health 200, LLCKNX2024-11-04
10192253028195DoverCardinal Health 200, LLCKNX2024-10-14
10192253028201DoverCardinal Health 200, LLCKNX2024-10-14
10192253028263DoverCardinal Health 200, LLCKNX2024-10-14