FDA.reportPublic FDA data

RCXL1Y High Efficiency Leukocyte Reduction Filter

Primary DI
30887691000592
Brand
RCXL1Y High Efficiency Leukocyte Reduction Filter
Company
HAEMONETICS CORPORATION
Model
RCXL1Y
Device description
RCXL1Y High Efficiency Leukocyte Reduction Filter with Attached Y-Type Administration Set for Single Unit Blood Transfusion
Published
2016-12-15
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
CAKMicrofilter, blood transfusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAKMicrofilter, Blood TransfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K873666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K873666000PALL LEUKOCYTE REMOVAL FILTER, BLOODPall Biomedical Products Co.1988-01-06CAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30887691000592PackageGS120In Commercial Distribution
10887691000598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088769100059230887691000592
1088769100059810887691000598

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion filterA sterile, microporous device inserted, e.g., into a blood transfusion line, to remove debris from blood being infused into a patient. When used for arterial blood the device may also be used to trap gaseous (air) bubbles. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)-537-2802pirdesk@Haemonetics.com

Regulatory Flags#

DUNS number
057827420
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10812747018203TEG500007-0442017-05-30
10812747018210TEG500007-0452017-05-30
10812747018296TEG6s HEMOSTASIS SYSTEM07-650-US2017-07-17
10812747018302TEG6s HEMOSTASIS SYSTEM07-651-US2017-08-18
10812747018326TEG6s HEMOSTASIS SYSTEM07-601-US2017-04-25
10812747018340TEG6S HEMOSTASIS SYSTEM07-662US2017-07-17
10812747018463Hemostasis System07-605-US2021-06-17
10812747018531Global Hemostasis - HN07-604-US2024-04-10
20812747018491Haemonetics TEG 6s07-664-US2021-06-17
20812747018514Haemonetics TEG 6s07-665US2021-06-18
20812747018002TEG5000 HEMOSTASIS SYSTEM07-0042017-06-16
20812747018019TEG5000 HEMOSTASIS SYSTEM07-0062017-06-16
20812747018026TEG5000 HEMOSTASIS SYSTEM07-0072017-06-16
20812747018033TEG5000 HEMOSTASIS SYSTEM07-0082017-06-16
10812747019859Haemonetics® NexSys PCS® System00620-NX2026-03-20
30812747019853Haemonetics® NexSys PCS® System00620-NX2026-03-20
30812747011659HAEMONETICS PCS 300 PLASMA COLLECTION SYSTEMPCS-300-US2017-11-01
10887691000116HaemoneticsPL1B2016-12-15
10887691000161Haemonetics EZ PrimeRCEZ1T2016-12-15
10887691000178HaemoneticsRCEZKS2022-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810197810460GVSGvs Tm, Inc.CAK2026-02-19
20810197810467GVSGvs Tm, Inc.CAK2026-02-19
10810197810170GVSGvs Tm, Inc.CAK2026-01-19
20810197810177GVSGvs Tm, Inc.CAK2026-01-19
04052682004308LeukoconnectFresenius Kabi AGCAK2022-06-02
14052682004305LeukoconnectFresenius Kabi AGCAK2022-06-02
10887691000178HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
10887691000543HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
30887691000172HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
30887691000547HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
10887691000666HaemoneticsHAEMONETICS CORPORATIONCAK2021-03-19
30887691000660HaemoneticsHAEMONETICS CORPORATIONCAK2021-03-19
20887691308745Leukocyte SC RCHAEMONETICS CORPORATIONCAK2017-06-16
30887691308742Leukocyte SC RCHAEMONETICS CORPORATIONCAK2017-06-16
10887691000673HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
10887691305792HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
30887691000677HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
30887691305796HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
10887691000550PXL 8HAEMONETICS CORPORATIONCAK2017-02-02
10887691000581RCXL1HAEMONETICS CORPORATIONCAK2017-02-02
10887691000680HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-02
30887691000554PXL 8HAEMONETICS CORPORATIONCAK2017-02-02
30887691000585RCXL1HAEMONETICS CORPORATIONCAK2017-02-02
30887691000684HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-02
10887691000758HaemoneticsHAEMONETICS CORPORATIONCAK2017-01-19
10887691001243LipiGuard SBHAEMONETICS CORPORATIONCAK2017-01-19
10887691304214Haemonetics Leukotrap SC RCHAEMONETICS CORPORATIONCAK2017-01-19
10887691305303HaemoneticsHAEMONETICS CORPORATIONCAK2017-01-19
30887691000752HaemoneticsHAEMONETICS CORPORATIONCAK2017-01-19
30887691001247LipiGuard SBHAEMONETICS CORPORATIONCAK2017-01-19