FDA.reportPublic FDA data

Geri-Gentle

Primary DI
10369771000150
Brand
Geri-Gentle
Company
GERI-GENTLE CORPORATION
Model
21-565
Device description
DRAIN BAG
Published
2016-11-11
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
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
10369771000150PrimaryGS10
50369771000153Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1036977100015010369771000150
5036977100015350369771000153

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Regulatory Flags#

DUNS number
361663839
Device count
20
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10369771000891Syringes Safety114662019-06-01
10369771000907Syringes Safety114672019-06-01
00369771000832Syringes Safety114662022-05-01
00369771001815NEEDLES 23x111-2312021-01-01
00369771001846NEEDLES 25x111-2512021-01-01
00369771001877NEEDLES 25x5/811-25582021-01-01
00369771001785Syringe 3ml11-3002021-01-01
00369771001525HMEF w/ Flextube19-HMEF1002020-06-01
00369771003642Sharps Collector 5QT111382023-11-01
00369771003659Sharps Collector 5QT111382023-11-01
00369771003420Prefilled Syrings11-10102023-09-01
00369771003390Pen Needle11-3052023-09-01
00369771003437Prefilled Syrings11-10102023-09-01
10369771000785Lancets Safety25-4572023-08-01
00369771003161Oxygen Concentrator19-50002023-08-01
20369771000782Lancets Safety25-4572023-08-01
00369771001273Gloves120972019-09-01
00369771001365Gloves122902019-09-01
00369771001389Gloves122912019-09-01
00369771001402Gloves12-3092019-09-01

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