FDA.reportPublic FDA data

McKesson

Primary DI
00612479268760
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
ph4575
Device description
pH Indicator Paper Nitrazine Paper
Published
2024-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LNWPaper, Obstetric Ph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNWPaper, Obstetric PhClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479268777PackageGS110In Commercial Distribution
00612479268784PackageGS14In Commercial Distribution
00612479268760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479268777006124792687776124792687770612479268777
00612479268784006124792687846124792687840612479268784
00612479268760006124792687606124792687600612479268760

GMDN Terms#

Term, Definition table
TermDefinition
Amniotic fluid leak detectorA device designed to help identify amniotic fluid in the vaginal secretions of a pregnant woman to confirm membrane rupture (normal or premature). The device typically involves a colour indicator that signals within the pH range of amniotic fluid (above 6.5) after contact. The device may consist of a panty liner with attached indicator strip, or a nitrazine-impregnated swab or paper. The device may be used in the home or in a clinical setting. This is a single-use device.

Regulatory Flags#

DUNS number
023904428
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974246462905Safecare Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2026-03-18
06974246462608Safecare Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2025-09-18
06974246462257Exploro Vaginal Health pH Test DeviceSafecare Biotech (Hangzhou) Co., Ltd.LNW2025-07-07
06974246462264Exploro Vaginal Health pH Test DeviceSafecare Biotech (Hangzhou) Co., Ltd.LNW2025-07-07
06974246462271Exploro Vaginal Health pH Test DeviceSafecare Biotech (Hangzhou) Co., Ltd.LNW2025-07-07
06974246462288Exploro Vaginal Health pH Test DeviceSafecare Biotech (Hangzhou) Co., Ltd.LNW2025-07-07
06974246462295Exploro Vaginal Health pH Test DeviceSafecare Biotech (Hangzhou) Co., Ltd.LNW2025-07-07
06974246462301Exploro Vaginal Health pH Test DeviceSafecare Biotech (Hangzhou) Co., Ltd.LNW2025-07-07
06974246461632Welcheck Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-10-16
06974246461649Welcheck Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-10-16
06974246461656Welcheck Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-10-16
06974246461366T Testahead Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-05-30
06974246461373T Testahead Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-05-30
06974246461328Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-05-10
06974246461335Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-05-10
06974246461342Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2024-05-10
00612479268777McKessonMCKESSON MEDICAL-SURGICAL INC.LNW2024-02-21
GYNXPH991GynexGYNEX CORPORATIONLNW2023-12-20
GYNXPH990GynexGYNEX CORPORATIONLNW2023-12-20
10673486001037Teco Diagnostics Vaginal pH Screening KitTECO DIAGNOSTICSLNW2023-11-03
06974246460932Testahead Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.LNW2023-09-05
00810143620016GenaCheck Vaginal pH Screening TestGenabio Diagnostics Inc.LNW2023-08-04
00810038634753Easy@home Feminine Vaginal pH Test Strip(30 tests)EASY HEALTHCARE CORPORATIONLNW2023-08-02
00810038634760Easy@home Feminine Vaginal pH Test Strip(10 tests)EASY HEALTHCARE CORPORATIONLNW2023-08-02
30810038634754Easy@home Feminine Vaginal pH Test Strip(30 tests)EASY HEALTHCARE CORPORATIONLNW2023-08-02
30810038634761Easy@home Feminine Vaginal pH Test Strip(10 tests)EASY HEALTHCARE CORPORATIONLNW2023-08-02
06970343581662HensoHenso Medical (Hangzhou) Co., Ltd.LNW2023-02-14
00850024942325Winx Health IncGet Stix Inc.LNW2021-05-15
00850024942370StixGet Stix Inc.LNW2021-05-15