FDA.reportPublic FDA data

Bedal

Primary DI
05430004283812
Brand
Bedal
Company
Bedal
Model
FlexGRIP EPI/PNB 20-16G
Catalog number
EP02-B
Device description
Sterilized - bulk
Published
2025-12-03
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
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
05430004283812PackageGS1400In Commercial Distribution
05430004283805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430004283812054300042838125430004283812
05430004283805054300042838055430004283805

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
Height6.4Millimeter
Length95Millimeter
Width60Millimeter

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
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
05430003674055FlexGRIPFlexGRIP Universal 11-18 FrUN1118; FLEX-M-10; FLEX-M-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

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