FDA.reportPublic FDA data

Enteral

Primary DI
05060590880746
Brand
Enteral
Company
GBUK ENTERAL LIMITED
Model
PHX0-6
Catalog number
PHX0-6
Device description
Enteral, Indicator Strips, pHX, Single Use 0–6
Published
2022-11-01
Public version status
Update
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
05060590880753PackageGS1100Not in Commercial Distribution
05060590880746PrimaryGS10
05060590880722Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060590880753050605908807535060590880753
05060590880746050605908807465060590880746
05060590880722050605908807225060590880722

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
100
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
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
05060999350253NutricareYNC10.092ISOSAF-ROWYNC10.092-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
05060590880432EnteralGBUK ENTERAL LIMITEDJLL2022-11-01
05060590880692EnteralGBUK 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