FDA.reportPublic FDA data

BD PhaSeal

Primary DI
30382905154035
Brand
BD PhaSeal
Company
BECTON DICKINSON PEN LIMITED
Model
515403
Catalog number
515403
Device description
Infusion Clamp (M25)
Published
2023-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
50382905154039PackageGS14In Commercial Distribution
30382905154035PrimaryGS10
00382905154034Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290515403950382905154039
3038290515403530382905154035
00382905154034003829051540343829051540340382905154034

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous line closed infusion system clampA non-sterile device in the form of a closable housing intended to enclose and secure the connection (e.g., Luer connection) between mating components of a closed infusion system [e.g., closed system drug transfer device (CSTD)] attached to a patient’s IV line to help prevent inadvertent separation of the closed infusion system components. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(844)823-5433customer_support@bd.com

Regulatory Flags#

DUNS number
988402590
Device count
25
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382905150630PhaSeal Optima5150635150632022-07-29
00382905153013BD PhaSeal5153015153012023-07-27
00382905152030BD PhaSeal5152035152032016-09-19
30382903205517BD Nano 2nd Gen3205513205512019-05-13
00382903201099BD Ultra-Fine3201093201092016-08-03
00382903201198BD Ultra-Fine3201193201192016-08-03
00382903201228BD Nano Ultra-Fine3201223201222016-08-03
00382903205509BD Nano 2nd Gen3205503205502019-05-08
00382903208807BD Ultra-Fine3208803208802016-08-03
00382903208814BD Ultra-Fine3208813208812016-08-03
00382903208821BD Ultra-Fine3208823208822016-08-03
00382903208838BD Nano Ultra-Fine3208833208832016-08-03
00382903282036BD Ultra-Fine3282033282032016-08-03
50382903205511BD Nano 2nd Gen3205513205512019-05-13
00382903201495BD Nano Ultra-Fine Pen Needles, 32G x 4MM (Sample)3201493201492016-08-03
00382903203673BD Ultra-Fine Pen Needles, 31G x 5MM (Sample)3203673203672016-08-03
00382903209811Pen Needles, 31G x 8MM3209813209812016-11-08
00382903209828Rite Aid Pen Needles, 31G x 5MM3209823209822016-11-10
00382903205400BD Nano Ultra-Fine Pen Needles, 32G x 4MM3205403205402017-08-15
50382905154053PhaSeal5154055154052023-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850087488303CeeportCEEPORT INC.KMK2026-05-29
00850087488310CeeportCEEPORT INC.KMK2026-05-29
00850087488327CeeportCEEPORT INC.KMK2026-05-29
00850087488334CeeportCEEPORT INC.KMK2026-05-29
00850087488341CeeportCEEPORT INC.KMK2026-05-29
00850087488358CeeportCEEPORT INC.KMK2026-05-29
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
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