Leukotrap WB System

Product NDC: 53157-262
11-digit product format: 531570262
Labeler code: 53157
Product ID: 53157-262_d67faebb-c273-36f0-e053-2a95a90a7ae8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Leukotrap WB System
Dosage form: KIT
Route: INTRAVENOUS
Labeler: Haemonetics Corporation
Application: BN820915
Marketing category: NDA
Marketing start: 1983-09-22
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53157-262		I	Inactivated by FDA		2026-09-09
excluded package	package	53157-262	53157-262-01	I	Inactivated by FDA		2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53157-262-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53157-262-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53157-262-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53157-262-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53157-262-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53157-262-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53157-262-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53157-262-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53157-262-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53157-262-01	2025-01-30	C162847	48780-1	2cef2736-8841-d83d-e063-dadaa90ab31f	Leukotrap WB Sytem

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53157-262-01	Leukotrap WB System	1 in 1 KIT	KIT	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53157-262	LEUKOTRAP WB SYSTEM KIT [HAEMONETICS CORPORATION]	1	Legacy NDC, 1 package rows	20220218_d67faebb-c272-36f0-e053-2a95a90a7ae8.zip

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leukotrap RC System	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	4c0dec79-1648-1cfd-e063-6394a90a88cc	2026-07-03		Exact identifier application number: BN820915
Leukotrap WB System - CP2D	CP2D/AS-3 - ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	44a82ea8-69bf-f061-e063-6394a90af3da	2026-07-03		Exact identifier application number: BN820915
Leukotrap WB system - CP2D	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	42ece7e1-1da1-7e5a-e063-6294a90ac803	2026-07-03		Exact identifier application number: BN820915
Leukotrap WB System - CP2D	CP2D/AS-3 - ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	44a7d200-13cb-c0b0-e063-6294a90aafad	2026-07-03		Exact identifier application number: BN820915
Leukotrap RC PL System	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	54eab581-bc48-f9f0-e063-6394a90a4b93	2026-06-25		Exact identifier application number: BN820915
Leukotrap WB system - CP2D	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	54fdf3cf-41df-af7d-e063-6294a90ab1e6	2026-06-24		Exact identifier application number: BN820915
Blood Collection System	CP2D/AS-3 TRIPLE WITH SAMPLING SYSTEM	GVS TM INC	54e8cfd2-f91b-8381-e063-6394a90a3f77	2026-06-23		Exact identifier application number: BN820915
Leukotrap RC PL System	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	54e9a497-7a94-44c9-e063-6294a90a84da	2026-06-23		Exact identifier application number: BN820915
Leukotrap RC PL System	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	54eb0462-cd00-4467-e063-6394a90aa371	2026-06-23		Exact identifier application number: BN820915
Leukotrap RC System	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	54eb3c81-5cc8-03c4-e063-6294a90a2065	2026-06-23		Exact identifier application number: BN820915
Leukotrap RC System	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	54ebb700-3bcf-d0e3-e063-6394a90a57c8	2026-06-23		Exact identifier application number: BN820915
AS-3	AS-3	GVS TM INC	3dfa3397-fc13-4659-e063-6394a90a5abc	2025-11-06	Warnings	Exact identifier application number: BN820915
CP2D	CP2D	GVS TM INC	3fa2e438-2ff0-a2df-e063-6394a90ac7b5	2025-11-06	Warnings	Exact identifier application number: BN820915

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53157-262-01	53157026201	1 KIT in 1 KIT (53157-262-01) * 63 mL in 1 BAG * 100 mL in 1 BAG	1 kit	1983-09-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leukotrap WB Sytem	Haemonetics Corporation \| Haemonetics Manufacturing Inc	2022-01-26	HUMAN PRESCRIPTION DRUG LABEL	1