FDA.reportPublic FDA data

Amnicators

Primary DI
25060259071304
Brand
Amnicators
Company
MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED
Model
N/a
Catalog number
MWAM5
Device description
Amniotic Fluid Indicator
Published
2023-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HIOSampler, Amniotic Fluid (Amniocentesis Tray)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIOSampler, Amniotic Fluid (Amniocentesis Tray)Obstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060259071300PrimaryGS10
25060259071304Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060259071300050602590713005060259071300
2506025907130425060259071304

GMDN Terms#

Term, Definition table
TermDefinition
Amniotic fluid leak detection device IVDAn in vitro diagnostic 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
216096750
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
05060259072727Sigma TranswabSigma TranswabMW168S2024-03-15
05060259075476DryswabN/aMW112BP2023-10-06
25060259075470DryswabN/aMW112BP2023-10-06
05060259076206DryswabN/a3250052023-10-06
05060259070013TranswabAmiesMW169P2023-10-05
05060259070020TranswabCharcoalMW169C2023-10-05
05060259070037TranswabAmiesMW1702023-10-05
05060259070051TranswabCharcoalMW1712023-10-05
05060259070075TranswabPlainMW172P2023-10-05
05060259070082TranswabCharcoalMW172C2023-10-05
05060259070112TranswabPlainMW173P2023-10-05
05060259070129TranswabCharcoalMW173C2023-10-05
05060259070136TranswabPlain AmiesMW175P2023-10-05
05060259070143TranswabCharcoalMW175C2023-10-05
05060259070181Sigma TranswabAmiesMW167S2023-10-05
05060259070198Sigma TranswabAmiesMW176S2023-10-05
05060259070204Sigma TranswabAmiesMW176SE22023-10-05
05060259070211Sigma TranswabAmiesMW176S32023-10-05
05060259070242Sigma TranswabAmiesMW177S2023-10-05
05060259070273TranswabStuarts PlainMW165P2023-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956476226CARDINAL HEALTHCardinal Health 200, LLCHIO2026-06-01
10198956418189CARDINAL HEALTHCardinal Health 200, LLCHIO2026-04-15
10198956345973CARDINAL HEALTHCardinal Health 200, LLCHIO2026-03-03
50198956345971CARDINAL HEALTHCardinal Health 200, LLCHIO2026-03-03
10198956309418CARDINAL HEALTHCardinal Health 200, LLCHIO2025-12-26
50198956309416CARDINAL HEALTHCardinal Health 200, LLCHIO2025-12-26
10198956251274CARDINAL HEALTHCardinal Health 200, LLCHIO2025-11-04
10198956224384CARDINAL HEALTHCardinal Health 200, LLCHIO2025-10-31
10198956063648CARDINAL HEALTHCardinal Health 200, LLCHIO2025-07-28
50198956063646CARDINAL HEALTHCardinal Health 200, LLCHIO2025-07-28
B098R404ROJFB0Aligned Medical SolutionsAligned Medical SolutionsHIO2025-03-17
B098R404ROJFB1Aligned Medical SolutionsAligned Medical SolutionsHIO2025-03-17
10197106799574CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-31
50197106799572CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-31
10197106781241CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-29
50197106781249CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-29
10197106784457CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-03
50197106784455CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-03
10197106704905CARDINAL HEALTHCardinal Health 200, LLCHIO2024-07-09
50197106704903CARDINAL HEALTHCardinal Health 200, LLCHIO2024-07-09
10197106602423CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
10197106615195CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
50197106602421CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
50197106615193CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
00191072215246ACSAMERICAN CONTRACT SYSTEMS, INC.HIO2024-01-12
10197106448694CARDINAL HEALTHCardinal Health 200, LLCHIO2023-12-19
50197106448692CARDINAL HEALTHCardinal Health 200, LLCHIO2023-12-19
00849233013766Busse Hospital DisposablesROBERT BUSSE & CO., INC.HIO2023-12-12
10849233013763Busse Hospital DisposablesROBERT BUSSE & CO., INC.HIO2023-12-12
05060259071300AmnicatorsMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDHIO2023-10-05