FDA.reportPublic FDA data

CHAS CATH-MATE STRAP

Primary DI
00610570176519
Brand
CHAS CATH-MATE STRAP
Company
Bird & Cronin, LLC
Model
08148200
Published
2022-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EYJHolder, Ureteral Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYJHolder, Ureteral CatheterGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00610570176519PrimaryGS10
00610570026180Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00610570176519006105701765196105701765190610570176519
00610570026180006105700261806105700261800610570026180

GMDN Terms#

Term, Definition table
TermDefinition
Urinary catheter holderA device designed to be attached to a patient's body to hold an indwelling urinary catheter line (e.g., Foley) in place. It consists of a wrap or adhesive strip/pad placed around the patient's thigh, abdomen, or pubis. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook, loop, clip) without creating excessive pressure on it and permitting visual inspection of the site. It is not designed to hold a urine collection bag. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
045975349
Device count
48
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610570191390B-Cool Chest & AB Binder Wrap081425212023-05-23
00610570191406B-Cool Chest & AB Binder Wrap081425222023-05-23
00610570191413B-Cool Chest & AB Binder Wrap081425242023-05-23
50610570191418B-Cool Chest & AB Binder Wrap081425232023-05-23
00610570191451B-Cool Super Sling Plus Universal (Complete Set)081482612023-02-20
00610570191581Short Anklizer Low Profile Walker XS081491372023-02-20
00610570191598Short Anklizer Low Profile Walker Small081491382023-02-20
00610570191604Short Anklizer Low Profile Walker Medium081491392023-02-20
00610570191611Short Anklizer Low Profile Walker Large081491402023-02-20
00610570191628Short Anklizer Low Profile Walker X-LG081491412023-02-20
00610570191444B-Cool Super Sling Universal (Sling Only)081482602023-02-16
00610570063277APNEA HEAD & CHIN STRAP081482232022-10-31
00610570088065CONTOURED CERV COLLAR 2" UNIV081400392022-10-31
00610570115655PRODY BULB HOLDER081482202022-10-31
00610570166756UNIVERSAL ARM SLING081400152022-08-01
00610570174607ENVELOPE STYLE ARM SLING XS081400612022-08-02
00610570174614ENVELOPE STYLE ARM SLING SM081400622022-08-02
00610570174621ENVELOPE STYLE ARM SLING MD081400632022-08-02
00610570174638ENVELOPE STYLE ARM SLING LG081400642022-08-02
00610570174645ENVELOPE STYLE ARM SLING XL081400652022-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850067913006TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
10850067913013TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
00612479281196McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479280717McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281219McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281233McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
05430004283539FlexGRIPBedalEYJ2025-12-03
05430004283799FlexGRIPBedalEYJ2025-12-03
05430003674291FlexGRIPBedalEYJ2025-12-01
06009900639604Another HandWISMED PL SP Z O OEYJ2025-03-17
10850058254330TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
10850058254361TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
50850058254376TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
10653160386360CenturionCENTURION MEDICAL PRODUCTS CORPORATIONEYJ2025-02-14
30618125134718Grip-LokPOSEY PRODUCTS, LLCEYJ2024-12-02
00618125192175Grip-LokTIDI PRODUCTS, LLCEYJ2024-12-02
20193489102724MEDLINEMEDLINE INDUSTRIES, INC.EYJ2024-09-19
10885632417115HalyardOWENS & MINOR DISTRIBUTION, INC.EYJ2024-07-29
G0960R867530959LineRising Eagle Medical LLCEYJ2024-01-30
80618125134782Grip-LokTIDI PRODUCTS, LLCEYJ2023-06-29
10048329000193CATH-SECURE LOCKM.C. JOHNSON CO., INC.EYJ2023-06-08
20193489102717MedlineMEDLINE INDUSTRIES, INC.EYJ2022-11-10
10618125135162Grip-LokTIDI PRODUCTS, LLCEYJ2022-10-18
10618125134776Grip-LokTIDI PRODUCTS, LLCEYJ2022-10-13
10618125134899Grip-LokTIDI PRODUCTS, LLCEYJ2022-10-13
00618125134786Grip-LokTIDI PRODUCTS, LLCEYJ2022-10-13
00610570176526CATH-MATE II CATHETER STRAPBird & Cronin, LLCEYJ2022-08-30
00610570176786CHAS II CATH-MATE STRAPBird & Cronin, LLCEYJ2022-08-30
00610570187379CATH-MATE II X-LONG STRAP 28"Bird & Cronin, LLCEYJ2022-08-30
00610570142309CHAS CATH-MATE STRAP 2/PKBird & Cronin, LLCEYJ2022-08-20