FDA.reportPublic FDA data

AmerisourceBergen

Primary DI
60368001115034
Brand
AmerisourceBergen
Company
BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
Model
11503
Device description
Fecal Diagnostic Kit, Disposable, Non -sterile
Published
2021-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60368001115034PackageGS16In Commercial Distribution
00368001115032PrimaryGS10
80368001115038Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6036800111503460368001115034
00368001115032003680011150323680011150320368001115032
8036800111503880368001115038

GMDN Terms#

Term, Definition table
TermDefinition
Rectal/faecal specimen collection kitA collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a rectal/faecal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, spatula], and a covered receptacle with or without an additive/medium (e.g., cell or nucleic acid preservation solution, Carey-Blair transport medium). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985523874
Device count
50
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
00368001112017AmerisourceBergen112012021-10-22
00368001112024AmerisourceBergen112022021-10-22
00368001112062AmerisourceBergen112062021-05-17
00368001112079AmerisourceBergen112072021-05-17
00368001112086AmerisourceBergen112082021-05-18
00368001112093AmerisourceBergen112092021-05-18
00368001112109AmerisourceBergen112102021-05-18
00368001105385AmerisourceBergen105382018-10-26
00368001105408AmerisourceBergen105402018-10-26
00368001105415AmerisourceBergen105412018-10-26
00368001105422AmerisourceBergen105422018-10-26
00368001105392AmerisourceBergen105392018-10-26
00368001103275AmerisourceBergen103272021-10-20
00368001103282AmerisourceBergen103282021-10-20
00368001103299AmerisourceBergen103292021-10-20
00368001103305AmerisourceBergen103302021-10-20
00368001103312AmerisourceBergen103312021-10-20
00368001103329AmerisourceBergen103322021-10-20
00368001103367AmerisourceBergen103362021-11-01
00368001103374AmerisourceBergen103372021-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G669CNPTLN1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, Non-SterileCorramedical Inc.NNK2026-04-07
00860013988029500 Single strip cards and 500 foil-LifelineADVANCE DX, INC.NNK2026-03-03
00860013988036500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)ADVANCE DX, INC.NNK2026-03-03
00860013988043Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988050Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988067Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03
00860013988074Advance Dx Blood Collection Card: Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00860013988098Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00827989007772Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007789Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007796Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
B24280EZEX21000Easy 2 Stool Extraction DeviceAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NNK2025-10-30
00810185250004TherapakTherapak LLCNNK2025-08-11
00810185250042TherapakTherapak LLCNNK2025-08-11
00810185250202TherapakTherapak LLCNNK2025-08-11
00810185250349TherapakTherapak LLCNNK2025-08-11
00810185250608TherapakTherapak LLCNNK2025-08-11
00810185250646TherapakTherapak LLCNNK2025-08-11
00810185250561TherapakTherapak LLCNNK2025-08-04
00810185250622TherapakTherapak LLCNNK2025-08-04
00840216128729QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
00840216128736QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
04038917086318Urine receptacle 500mlSarstedt Aktiengesellschaft & Co.KGNNK2025-05-19
00860013899264Paternity Test Kit 50Ditek Consulting, LLCNNK2025-05-06
00860013899288Paternity Test Kit 25Ditek Consulting, LLCNNK2025-05-06
00860011770268Covid 19 Testing KitDitek Consulting, LLCNNK2025-05-01
00613647027059FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027066FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027073FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027080FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30