FDA.reportPublic FDA data

BOEHRINGER® CareDry™ System

Primary DI
10816286021076
Brand
BOEHRINGER® CareDry™ System
Company
BOEHRINGER LABORATORIES, LLC
Model
7660
Device description
CareDry™ System
Published
2021-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NZUCollector, Urine, Powered, Non Indwelling Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZUCollector, Urine, Powered, Non Indwelling CatheterGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816286021073PackageGS120In Commercial Distribution
40816286021077PackageGS1600In Commercial Distribution
10816286021076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081628602107320816286021073
4081628602107740816286021077
1081628602107610816286021076

GMDN Terms#

Term, Definition table
TermDefinition
Female wearable urinal, single-useA non-sterile, urine drainage device designed for women that typically consists of a moulded collection cup, which may be partially inserted into the vagina, and a flexible tube attached to a collector that is specially formed to securely fit around the female genitals to provide a route to channel urine, via a tube, into a collection bag. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
610-278-0900info@boehringerlabs.com

Regulatory Flags#

DUNS number
079991657
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
10816286021182Boehringer Surgical Suction Device50302025-11-24
20816286021189Boehringer Surgical Suction Device50302025-11-24
10816286021175UpLivt 52002025-07-16
70816286021177UpLivt 52002025-07-16
10816286021120BOEHRINGER® ViSiGi Lux 36 Fr5336SB2025-05-20
10816286021137BOEHRINGER® ViSiGi Lux 40 Fr5340SB2025-05-20
30816286021124BOEHRINGER® ViSiGi Lux 36 Fr5336SB2025-05-20
30816286021131BOEHRINGER® ViSiGi Lux 40 Fr5340SB2025-05-20
10816286021151BOEHRINGER® CareDry™ Male System76802024-12-31
20816286021158BOEHRINGER® CareDry™ Male System76802024-12-31
10816286021168BOEHRINGER® Offset Mount - Four Inches90612024-12-31
10816286020659BOEHRINGER® Accessory Bulb for ViSiGi 3D™ Sleeve Gastrectomy Calibration System52502016-08-01
10816286021083TruLim Length Indicating Device501050102022-06-21
10816286020932BOEHRINGER® Smoke Removal System57002020-02-01
10816286020079BOEHRINGER® Care 4™ Suction Regulator, Intermittent/Continuous, 0-200, off/ cont384438442016-08-01
10816286021144BOEHRINGER® CareDry™ System76652023-12-29
20816286021141BOEHRINGER® CareDry™ System76652023-12-29
10816286020949BOEHRINGER® CareDry™ Regulator PST763076302020-01-15
10816286021014BOEHRINGER® Disposable Regulator 100-150mmHg765076502020-04-07
10816286021038BOEHRINGER® CareDry™ Wand764076402021-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741231025PureWickC. R. Bard, Inc.NZU2026-05-07
00801741234514PureWickC. R. Bard, Inc.NZU2026-05-07
00801741231537PureWickC. R. Bard, Inc.NZU2026-05-06
10801741239219PureWickC. R. Bard, Inc.NZU2026-05-05
07333387056623Surity Male External CatheterWellspect ABNZU2026-04-27
00801741231001PureWickC. R. Bard, Inc.NZU2026-02-06
00801741231018PureWickC. R. Bard, Inc.NZU2026-02-06
07333387056630Surity Female External CatheterWellspect ABNZU2025-12-19
07333387055329Surity Female External CatheterWellspect ABNZU2025-12-19
10816286021151BOEHRINGER® CareDry™ Male SystemBOEHRINGER LABORATORIES, LLCNZU2024-12-31
20816286021158BOEHRINGER® CareDry™ Male SystemBOEHRINGER LABORATORIES, LLCNZU2024-12-31
00801741226960PureWickC. R. Bard, Inc.NZU2024-07-29
00801741226984PureWickC. R. Bard, Inc.NZU2024-07-29
10801741226967PureWickC. R. Bard, Inc.NZU2024-07-29
10801741226981PureWickC. R. Bard, Inc.NZU2024-07-29
00801741226465PureWickC. R. Bard, Inc.NZU2024-05-31
00801741226953PureWickC. R. Bard, Inc.NZU2024-05-31
10801741226462PureWickC. R. Bard, Inc.NZU2024-05-31
10801741226950PureWickC. R. Bard, Inc.NZU2024-05-31
07290109270203UriCap Base kit+ box of 30TILLA CARE LTDNZU2024-04-02
07290109270210UriCap Female + TILLA CARE LTDNZU2024-04-02
07290109270227Home Sample Kits (box of 5)TILLA CARE LTDNZU2024-04-02
07290109270234Home Base Kit (30-Day Supply)TILLA CARE LTDNZU2024-04-02
10816286021144BOEHRINGER® CareDry™ SystemBOEHRINGER LABORATORIES, LLCNZU2023-12-29
20816286021141BOEHRINGER® CareDry™ SystemBOEHRINGER LABORATORIES, LLCNZU2023-12-29
07290109270197Tube Connector TILLA CARE LTDNZU2023-10-02
00801741219153PureWick MaleC. R. Bard, Inc.NZU2022-08-01
10801741219150PureWick MaleC. R. Bard, Inc.NZU2022-08-01
07290109270173UriCap Base kit box of 30TILLA CARE LTDNZU2022-06-14
07290109270180UriCap Base kit box of 5TILLA CARE LTDNZU2022-06-14