FDA.report

Bedal

Primary DI
00543000025609
Brand
Bedal
Company
Bedal
Model
bedal flex epi/pnb
Catalog number
EPNS02
Device description
Non Sterilized
Published
2022-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KGZAccessories, Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00543000025609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00543000025609005430000256095430000256090543000025609

GMDN Terms

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

TypeValueUnit
Height6.4Millimeter
Length95Millimeter
Width60Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods

Method
Radiation Sterilization

Contacts

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
true

Other Devices From This Company

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

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