FDA.reportPublic FDA data

Leukotrap RC System

Product NDC
87069-129
11-digit product format
870690129
Labeler code
87069
Product ID
87069-129_4c0dec79-1649-1cfd-e063-6394a90a88cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CP2D/AS-3 triple blood bag unit with in-line RC2D filter and sampling system
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
GVS TM INC
Application
BN820915
Marketing category
NDA
Marketing start
2026-03-02
Substance
DEXTROSE, UNSPECIFIED FORM
Active strength
3.57 g/70mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leukotrap RC System
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE, UNSPECIFIED FORM3.57 g/70mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IY9XDZ35W2Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
54eb3c81-5cc8-03c4-e063-6294a90a2065Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87069-129-63Leukotrap RC System18 in 1 CARTONSOLUTION181
87069-129-63Leukotrap RC System3 in 1 POUCHSOLUTION31

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leukotrap RC SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC4c0dec79-1648-1cfd-e063-6394a90a88cc2026-07-03Exact identifier
application number: BN820915
ndc (product): 87069-129
Leukotrap WB System - CP2DCP2D/AS-3 - ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC44a82ea8-69bf-f061-e063-6394a90af3da2026-07-03Exact identifier
application number: BN820915
Leukotrap WB system - CP2DCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC42ece7e1-1da1-7e5a-e063-6294a90ac8032026-07-03Exact identifier
application number: BN820915
Leukotrap WB System - CP2DCP2D/AS-3 - ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC44a7d200-13cb-c0b0-e063-6294a90aafad2026-07-03Exact identifier
application number: BN820915
Leukotrap RC PL SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eab581-bc48-f9f0-e063-6394a90a4b932026-06-25Exact identifier
application number: BN820915
Blood Collection SystemCP2D/AS-3 TRIPLE WITH SAMPLING SYSTEMGVS TM INC54e8cfd2-f91b-8381-e063-6394a90a3f772026-06-23Exact identifier
application number: BN820915
Leukotrap RC PL SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eb0462-cd00-4467-e063-6394a90aa3712026-06-23Exact identifier
application number: BN820915
Leukotrap RC SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eb3c81-5cc8-03c4-e063-6294a90a20652026-06-23Exact identifier
application number: BN820915
ndc (product): 87069-129
Leukotrap RC SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54ebb700-3bcf-d0e3-e063-6394a90a57c82026-06-23Exact identifier
application number: BN820915
ndc (product): 87069-129
AS-3AS-3GVS TM INC3dfa3397-fc13-4659-e063-6394a90a5abc2025-11-06WarningsExact identifier
application number: BN820915
CP2DCP2DGVS TM INC3fa2e438-2ff0-a2df-e063-6394a90ac7b52025-11-06WarningsExact identifier
application number: BN820915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87069-129-62870690129626 POUCH in 1 CARTON (87069-129-62) / 3 BAG in 1 POUCH / 70 mL in 1 BAG6 pouch2026-06-230Current
87069-129-638706901296318 POUCH in 1 CARTON (87069-129-63) / 3 BAG in 1 POUCH / 70 mL in 1 BAG18 pouch2026-03-02NoNoCurrent
87069-129-64870690129646 POUCH in 1 CARTON (87069-129-64) / 3 BAG in 1 POUCH / 70 mL in 1 BAG6 pouch2026-06-230Current