FDA.reportPublic FDA data

BD PhaSeal

Primary DI
50382905154039
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
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
988402590
Device count
25
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
false
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
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
10618125192592Grip-LokTIDI PRODUCTS, LLCKMK2026-06-09
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