FDA.reportPublic FDA data

Centurion

Primary DI
10653160283225
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
SV577UDT
Catalog number
SV577UDT
Device description
SORBAVIEW SHIELD 577
Published
2022-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10653160283225PackageGS1100In Commercial Distribution
20653160283222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1065316028322510653160283225
2065316028322220653160283222

GMDN Terms#

Term, Definition table
TermDefinition
Wearable percutaneous catheter/tube holderA device designed to fix a percutaneous catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body without suturing; it may additionally be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, strip, or bandage that will attach to the patient's skin, sometimes with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure) or a mechanical closure, to hold the catheter/tube in place. It may include a transparent film portion intended for fixation site monitoring. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00653160294248CenturionMNS101552016-11-11
00653160315974CenturionCIT66352018-04-09
00653160284218CenturionCIT59202017-03-03
00653160274882CenturionPE31802018-02-11
00653160389753CenturionDM485BDM485B2025-09-17
00653160389296CenturionBT235BBT235B2025-08-24
00653160389319CenturionCSS640ACSS640A2025-08-24
00653160389494CenturionDT23104DT231042025-08-24
00653160388992CenturionSUT14785ASUT14785A2025-08-18
00653160389357CenturionDT23103DT231032025-08-18
00653160389067CenturionDYNDV2722DYNDV27222025-08-09
00653160389074CenturionSUT19525ASUT19525A2025-08-09
00653160389159CenturionIVS1090BIVS1090B2025-08-09
00653160388978CenturionMNS10875BMNS10875B2025-08-02
00653160386936CenturionIVS4222IVS42222025-07-21
00653160388909CenturionSUT21465BSUT21465B2025-07-21
00653160388848CenturionDYNDC3166DDYNDC3166D2025-07-18
00653160388732CenturionSUT19955BSUT19955B2025-07-14
00653160388770CenturionDM875ADM875A2025-07-14
00653160388794CenturionSUT12485ASUT12485A2025-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05430004283935FlexGRIPBedalKMK2025-12-19
05430000258494FlexGRIPBedalKMK2025-12-03
05430000258654Bedal BedalKMK2025-12-03
05430003674017FlexGRIPBedalKMK2025-12-03
05430003674062FlexGRIPBedalKMK2025-12-03
05430003674239Bedal BedalKMK2025-12-03
05430003674260Bedal BedalKMK2025-12-03
05430004283812Bedal BedalKMK2025-12-03
05430003674116FlexGRIPBedalKMK2025-12-02
05430003674147FlexGRIPBedalKMK2025-12-02
05430003674321FlexGRIPBedalKMK2025-12-02
05430003674468FlexGRIPBedalKMK2025-12-02
05430003674499FlexGRIPBedalKMK2025-12-02
05430003674956FlexGRIPBedalKMK2025-12-02
05430003674987FlexGRIPBedalKMK2025-12-02
05430004283270FlexGRIPBedalKMK2025-12-02
05430004283355FlexGRIPBedalKMK2025-12-02
05430004283386FlexGRIPBedalKMK2025-12-02
05430004283416FlexGRIPBedalKMK2025-12-02
05430004283447FlexGRIPBedalKMK2025-12-02
05430004283478FlexGRIPBedalKMK2025-12-02
05430004283553FlexGRIPBedalKMK2025-12-02
05430004283584FlexGRIPBedalKMK2025-12-02
05430004283737FlexGRIPBedalKMK2025-12-02
05430004283768FlexGRIPBedalKMK2025-12-02
05430004283867FlexGRIPBedalKMK2025-12-02
05430000258173Bedal BedalKMK2025-12-01
05430000258258FlexGRIPBedalKMK2025-12-01
05430003674178FlexGRIPBedalKMK2025-12-01
05430003674208FlexGRIPBedalKMK2025-12-01