FDA.reportPublic FDA data

Bedal

Primary DI
05430000258333
Brand
Bedal
Company
Bedal
Model
bedal pivc
Catalog number
PV02
Device description
Sterilized
Published
2022-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGZAccessories, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05430000258333PackageGS125In Commercial Distribution
05430000258340PackageGS1200In Commercial Distribution
05430000258326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430000258333054300002583335430000258333
05430000258340054300002583405430000258340
05430000258326054300002583265430000258326

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer semi-permeable film dressing, adhesiveA transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height15Millimeter
Length70Millimeter
Width44.8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3211286905info@bedal.be

Regulatory Flags#

DUNS number
370066406
Device count
1
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
true
Expiration date on label
true
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
05430004283935FlexGRIPFlexGRIP Neo. PICCPICCNEO-B2025-12-19
05430000258494FlexGRIPFlexGRIP Universal 11-18 FrUN11182025-12-03
05430000258654Bedal FlexGRIP CVC 4.5-9 FrCVC459HS2025-12-03
05430003674017FlexGRIPFlexGRIP Universal 5-11 FrFLEXS-10; FLEXS-502025-12-03
05430003674062FlexGRIPFlexGRIP Universal 11-18 FrUN1118; FLEX-M-10; FLEX-M-502025-12-03
05430003674239Bedal FlexGRIP Jr. CVC 3-6 FrCVCJR36HS2025-12-03
05430003674260Bedal FlexGRIP Jr. CVC 3-6 FrCVCJR36002025-12-03
05430004283539FlexGRIPFlexGRIP Foley 11-18 FrFOL1118-B2025-12-03
05430004283799FlexGRIPFlexGRIP Foley 11-18 FrFOL1118-B2025-12-03
05430004283812Bedal FlexGRIP EPI/PNB 20-16GEP02-B2025-12-03
05430003674116FlexGRIPFlexGRIP Jr. PIVCPIVCJR2025-12-02
05430003674147FlexGRIPFlexGRIP Jr. NEXNEXJR2025-12-02
05430003674321FlexGRIPFlexGRIP Universal 18-25 FrUN18252025-12-02
05430003674468FlexGRIPFlexGRIP Jr. AlphaALPHAJR2025-12-02
05430003674499FlexGRIPFlexGRIP Neo. AlphaALPHANEO2025-12-02
05430003674956FlexGRIPFlexGRIP Neo. PIVCPIVCNEO2025-12-02
05430003674987FlexGRIPFlexGRIP Neo. A1PICCNEO2025-12-02
05430004283270FlexGRIPFlexGRIP Neo. PIVC FSPIVCNEOFS2025-12-02
05430004283355FlexGRIPFlexGRIP Jr. AlphaALPHAJR2025-12-02
05430004283386FlexGRIPFlexGRIP Neo. AlphaALPHANEO2025-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20653160392375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KGZ2026-02-26
06937440443811YiGaoMedZhejiang Yigao Medical Technology Co., Ltd.KGZ2025-12-09
06937440443828YiGaoMedZhejiang Yigao Medical Technology Co., Ltd.KGZ2025-12-09
40198459435202MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
40704411017883AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.KGZ2025-06-23
04048223118702FixoLongPajunk GmbH MedizintechnologieKGZ2025-04-04
05708932767811SopranoColoplast A/SKGZ2025-03-26
20192253053606DevonCardinal Health 200, LLCKGZ2025-03-25
20192253042020DevonCardinal Health 200, LLCKGZ2025-03-07
20192253042037DevonCardinal Health 200, LLCKGZ2025-03-07
00840306834936Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-11
00840306835155Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-11
00840306835124Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-10
00860012804405BladeClearPATHWAY MEDTECH, LLCKGZ2024-11-04
00860012804412BladeClearPATHWAY MEDTECH, LLCKGZ2024-11-04
00840306836039Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-23
10884521811546RitusCovidien LPKGZ2024-10-21
00840306835162Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835179Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835186Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835209Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835216Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835223Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835230Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835247Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
05708932767545Insertion ToolCOLOPLAST CORP.KGZ2024-09-27
50382904275650BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-22
50382904275612BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
50382904275629BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
50382904275636BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20