FDA.reportPublic FDA data

Alaris, SmartSite

Primary DI
10885403422294
Brand
Alaris, SmartSite
Company
BD Switzerland Sàrl
Model
11627697
Catalog number
11627697
Device description
GRAVITY SET DUAL 10DP CKV 1SS 4WS
Published
2017-08-08
Public version status
Update
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
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403422292PackageGS120In Commercial Distribution
10885403422294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540342229250885403422292
1088540342229410885403422294

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
482631558
Device count
1
DM exempt
false
Premarket exempt
false
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
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30382905156299BD PhaSeal Optima5156295156292026-01-09
30382905156282BD PhaSeal Optima5156285156282025-12-19
10885403226076BD VersaSafe1000M1000M2016-09-22
10885403230622MaxZeroMZ9279MZ92792016-11-04
10885403230127BD MaxPlusMP2202-CMP2202-C2016-09-22
10885403230158MaxPlusMP5312-CMP5312-C2016-09-22
10885403236204MaxGuardME1248ME12482016-09-22
10885403236860BD MaxPlusMP9014-CMP9014-C2016-09-22
10885403237072BD MaxPlusMP9232-CMP9232-C2016-09-22
10885403237119BD MaxPlusMP9236-CMP9236-C2016-09-22
10885403274770BD MaxPlusMP9256-CMP9256-C2016-09-22
10885403223228MaxPlusMP1000-CMP1000-C2016-09-22
10885403232985MaxPlusMP1000MP10002016-09-22
10885403237416BD MaxGuardMV0510MV05102016-09-22
10885403240621MaxZeroMZ9226MZ92262016-09-22
10885403240720MaxZeroMZ9267MZ92672016-09-22
10885403240737MaxZeroMZ9270MZ92702016-09-22
10885403240744MaxZeroMZ9271MZ92712016-09-22
10885403240751MaxZeroMZ9274MZ92742016-09-22
10885403240768MaxZeroMZ9275MZ92752016-09-22

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