FDA.reportPublic FDA data

BD PhaSeal™ Optima Infusion Clamp M25-O

Primary DI
30382905150853
Brand
BD PhaSeal™ Optima Infusion Clamp M25-O
Company
BECTON DICKINSON PEN LIMITED
Model
515085
Catalog number
515085
Device description
M25-O Infusion Clamp
Published
2020-06-30
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

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
30382905150853PackageGS125In Commercial Distribution
50382905150857PackageGS14In Commercial Distribution
00382905150852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290515085330382905150853
5038290515085750382905150857
00382905150852003829051508523829051508520382905150852

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
988402590
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
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
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