FDA.reportPublic FDA data

Infinity Low Volume Enteral Screw Cap with EnFit Connector

Primary DI
38148440000280
Brand
Infinity Low Volume Enteral Screw Cap with EnFit Connector
Company
ZEVEX INTERNATIONAL, INC.
Model
INFOCAP-A
Published
2016-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PIFGastrointestinal Tubes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38148440000280PackageGS130In Commercial Distribution
18148440000286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3814844000028038148440000280
1814844000028618148440000286

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding bag/bottleAn empty pouch or bottle made of plastic or glass intended to contain a fluid of nutrients for administration to a patient through an enteral tube that provides direct access to the stomach, duodenum, or jejunum; it is not intended for intravenous (IV) administration. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an enteral feeding set] and is not intended to be directly connected to the invasive feeding tube. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
612746933
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
18148440000101Infinity150745-0012018-08-03
18148440000118Infinity150745-0022018-08-03
18148440000125Infinity150745-0032018-08-03
18148440000132Infinity150749-0012018-08-03
18148440000149Infinity150749-0012018-08-03
18148440000156Infinity1507512018-08-03
18148440000163Infinity1507532018-08-03
10814844000105InfinityInfinity Mini Backpack, Red50745-0012021-11-03
10814844000112InfinityInfinity Mini Backpack, Green/Gray50745-0022021-11-03
10814844000129InfinityInfinity Mini Backpack, Black50745-0032021-11-03
10814844000136InfinityInfinity Super Mini Backpack, Black50749-0012021-11-03
10814844000143InfinityInfinity Super Mini Backpack, Green/Gray50749-0012021-11-03
10814844000150InfinityInfinity Waist Pack, Black507512021-11-03
10814844000167InfinityInfinity Adult Pack, Black507532021-11-03
10814844001584InfinityPCK100150745-0012021-05-06
10814844001591InfinityPCK10022021-05-06
10814844001607InfinityPCK10032021-05-06
10814844001614InfinityPCK20012021-05-06
10814844001621InfinityPCK200250749-0012021-05-06
10814844001638InfinityPCK30012021-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253012460Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012484Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012507Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012521Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012989Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253013009Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253060928Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253068764CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068771CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068788CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068795CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068801CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068818CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068825CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068832CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253011449CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011463CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011487CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011517CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011531CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011555CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011579CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011593CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011616CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10850016172485KBMEDKB Medical (group), Inc.PIF2025-05-21
10850016172492KBMEDKB Medical (group), Inc.PIF2025-05-21
10192253007572ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007596ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007619ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007633ArgyleCardinal Health 200, LLCPIF2025-04-24