FDA.reportPublic FDA data

FlexGRIP

Primary DI
05430003674055
Brand
FlexGRIP
Company
Bedal
Model
FlexGRIP Universal 11-18 Fr
Catalog number
UN1118; FLEX-M-10; FLEX-M-50
Device description
Sterilized Product- Distributed by Cook
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMKDevice, Intravascular Catheter Securement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMKDevice, Intravascular Catheter SecurementGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05430003674062PackageGS110In Commercial Distribution
05430003674079PackageGS1240In Commercial Distribution
05430003674086PackageGS150In Commercial Distribution
05430003674093PackageGS1200In Commercial Distribution
05430003674055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430003674062054300036740625430003674062
05430003674079054300036740795430003674079
05430003674086054300036740865430003674086
05430003674093054300036740935430003674093
05430003674055054300036740555430003674055

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.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+3211286902info@bedal.be

Regulatory Flags#

DUNS number
370066406
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
05430000258005FlexGRIPFlexGRIP Universal 5-11 FrUN511-CAP2026-04-30
05430000258753FlexGRIPFlexGRIP Universal 11-18 FrUN1118-CAP2026-04-30
05430004283492FlexGRIPFlexGRIP Universal 18-25 FrUN1825-CAP2026-04-30
05430004283928FlexGRIPFlexGRIP Neo. PICCPICCNEO-B2025-12-19
05430004283935FlexGRIPFlexGRIP Neo. PICCPICCNEO-B2025-12-19
05430000258647Bedal FlexGRIP CVC 4.5-9 FrCVC459HS2025-12-03
05430003674000FlexGRIPFlexGRIP Universal 5-11 FrFLEXS-10; FLEXS-502025-12-03
05430003674222Bedal FlexGRIP Jr. CVC 3-6 FrCVCJR36HS2025-12-03
05430003674253Bedal FlexGRIP Jr. CVC 3-6 FrCVCJR36002025-12-03
05430004283522FlexGRIPFlexGRIP Foley 11-18 FrFOL1118-B2025-12-03
05430004283782FlexGRIPFlexGRIP Foley 11-18 FrFOL1118-B2025-12-03
05430004283805Bedal FlexGRIP EPI/PNB 20-16GEP02-B2025-12-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10618125192585Grip-LokTIDI PRODUCTS, LLCKMK2026-04-15
10816000014070ARROWTELEFLEX INCORPORATEDKMK2025-09-16
10801741082983StatLockBard Access Systems, Inc.KMK2025-05-02
10801741087582StatLockBard Access Systems, Inc.KMK2025-05-02
10816000013868ARROWTELEFLEX INCORPORATEDKMK2025-04-04
10618125192141Grip-LokTIDI PRODUCTS, LLCKMK2024-12-02
10885632416309HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-30
10885632416279HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416286HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416293HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10618125135148Grip-LokTIDI PRODUCTS, LLCKMK2024-04-22
20653160370694CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370700CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370717CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370724CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370731CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370748CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370755CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160371073CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-02-02
20653160369322MEDLINEMEDLINE INDUSTRIES, INC.KMK2023-12-01
30382905154035BD PhaSealBECTON DICKINSON PEN LIMITEDKMK2023-09-15
10686004000023UltraDressingI.V. House, Inc.KMK2023-07-21
10686004000030UtraDressingI.V. House, Inc.KMK2023-07-21
10686004000054UltraDressingI.V. House, Inc.KMK2023-07-21
10686004000320UltraDomeI.V. House, Inc.KMK2023-07-21
20686004000013UltraDomeI.V. House, Inc.KMK2023-07-21
20686004000303UltraDomeI.V. House, Inc.KMK2023-07-21
20686004000310UltraDomeI.V. House, Inc.KMK2023-07-21
30686004000041UltraDressingI.V. House, Inc.KMK2023-07-21
20653160358692CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2023-02-06