FDA.reportPublic FDA data

Enteral

Primary DI
05060590880432
Brand
Enteral
Company
GBUK ENTERAL LIMITED
Model
ENT-PHSPPX
Catalog number
ENT-PHSPPX
Device description
Enteral, Indicator Strips, pH, Single Use 2 – 9
Published
2022-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
JLLTUBELESS ANALYSIS, GASTRIC ACIDITY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLLTubeless Analysis, Gastric AcidityClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060590880449PackageGS150In Commercial Distribution
05060590880432PrimaryGS10
05060590880425Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060590880449050605908804495060590880449
05060590880432050605908804325060590880432
05060590880425050605908804255060590880425

GMDN Terms#

Term, Definition table
TermDefinition
Gastric pH stripA paper strip impregnated with an indicator solution (e.g., universal indicator) intended to be used to measure the pH of gastric aspirate to verify the depth of placement of a nasogastric feeding tube. The strip changes colour when exposed to an acidic or basic solution. This is a single-use device.

Regulatory Flags#

DUNS number
216643186
Device count
25
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060999351564EnteralESCF.075-ISOSAF-USESCF.075-ISOSAF-US2025-08-20
05060999351595EnteralESCF.150-ISOSAF-USESCF.150-ISOSAF-US2025-08-20
05060999351625EnteralBESCF.075-ISOSAF-USBESCF.075-ISOSAF-US2025-08-20
05060999351656EnteralBESCF.143-ISOSAF-USBESCF.143-ISOSAF-US2025-08-20
05060999351571EnteralESCF.075-ISOSAF-USESCF.075-ISOSAF-US2025-08-20
05060999351601EnteralESCF.150-ISOSAF-USESCF.150-ISOSAF-US2025-08-20
05060999351632EnteralBESCF.075-ISOSAF-USBESCF.075-ISOSAF-US2025-08-20
05060999351670EnteralBESCF.143-ISOSAF-USBESCF.143-ISOSAF-US2025-08-20
05060590880746EnteralPHX0-6PHX0-62022-11-01
05060590883754EnteralEISO-35EISO-352022-10-28
05060460844083EnteralESCF.075-ISOSAFESCF.075-ISOSAF2022-10-28
05060460844113EnteralESCF.150-ISOSAFESCF.150-ISOSAF2022-10-28
05060999350017NutricareYNC06.050ISOSAF-ROWYNC06.050-US2024-10-29
05060999350048NutricareYNC06.080ISOSAF-ROWYNC06.080-US2024-10-29
05060999350079NutricareYNC06.110ISOSAF-ROWYNC06.110-US2024-10-29
05060999350109NutricareYNC08.050ISOSAF-ROWYNC08.050-US2024-10-29
05060999350130NutricareYNC08.080ISOSAF-ROWYNC08.080-US2024-10-29
05060999350161NutricareYNC08.092ISOSAF-ROWYNC08.092-US2024-10-29
05060999350192NutricareYNC08.110ISOSAF-ROWYNC08.110-US2024-10-29
05060999350222NutricareYNC08.120ISOSAF-ROWYNC08.120-US2024-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979259840009PEPFASTRD Biomed (Changsha) LimitedJLL2025-12-23
06979259840016PEPFASTRD Biomed (Changsha) LimitedJLL2025-12-23
06979259840023PEPFASTRD Biomed (Changsha) LimitedJLL2025-12-23
05060590880401EnteralGBUK ENTERAL LIMITEDJLL2022-11-01
05060590880692EnteralGBUK ENTERAL LIMITEDJLL2022-11-01
05060590880746EnteralGBUK ENTERAL LIMITEDJLL2022-11-01
00861145002607RightSpotpH®RIGHTBIO/METRICS INC.JLL2018-11-10
40861145002605RightSpotpH®RIGHTBIO/METRICS INC.JLL2018-11-10
00709078006050FeedSafeWESTMED, INC.JLL2018-09-25
00709078006067FeedSafeWESTMED, INC.JLL2018-09-25
10709078006057FeedSafeWESTMED, INC.JLL2018-09-25
10709078006064FeedSafeWESTMED, INC.JLL2018-09-25