FDA.reportPublic FDA data

ARROW

Primary DI
30816000013862
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN922101
Catalog number
9066-VC-005
Device description
EZ-Stabilizer
Published
2025-04-04
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
20816000013865PackageGS15In Commercial Distribution
30816000013862PackageGS120In Commercial Distribution
10816000013868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081600001386520816000013865
3081600001386230816000013862
1081600001386810816000013868

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-fixation skin adhesive tape, non-siliconeA long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight; Keep Dry.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

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