FDA.reportPublic FDA data

BodyMed

Primary DI
00815991025006
Brand
BodyMed
Company
BOXOUT, LLC
Model
BDMEFS60
Device description
BodyMed ENFit Tip Syringe 60 ml
Published
2023-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PNREnteral Syringes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNREnteral Syringes With Enteral Specific ConnectorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182649000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182649000Enteral Feeding Syringes with Enfit ConnectorsJiangsu Kangbao Medical Equipment Co., Ltd.2018-11-09PNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815991025003PackageGS150In Commercial Distribution
20815991025000PackageGS1200In Commercial Distribution
00815991025006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081599102500310815991025003
2081599102500020815991025000
00815991025006008159910250068159910250060815991025006

GMDN Terms#

Term, Definition table
TermDefinition
ENFit oral/enteral syringe, single-useA manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
066689993
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815991024405BodyMedBDMNEBCOM2022-07-01
00815991024412BodyMedBDMNEBDOG2022-07-01
00815991025167BodyMedBDMNEBCOMREU2025-07-17
00815991024047BodyMedBDMNTRGVMEDBDMNTRGVMED2024-12-04
00815991024054BodyMedBDMNTRGVSMBDMNTRGVSM2024-12-04
00815991024061BodyMedBDMNTRGVXLGBDMNTRGVXLG2024-12-04
00815991024078BodyMedBDMNTRGVXSBDMNTRGVXS2024-12-04
00815991024030BodyMedBDMNTRGVLRGBDMNTRGVLRG2024-12-04
20815991024041BodyMedBDMNTRGVMEDBDMNTRGVMED2024-12-04
20815991024058BodyMedBDMNTRGVSMBDMNTRGVSM2024-12-04
20815991024065BodyMedBDMNTRGVXLGBDMNTRGVXLG2024-12-04
20815991024072BodyMedBDMNTRGVXSBDMNTRGVXS2024-12-04
00815991025181BodyMedBDMPULSEOXBDMPULSEOX2024-10-11
20815991025185BodyMedBDMPULSEOXBDMPULSEOX2024-10-11
00815802010122BodyMedZZHP1427ZZHP14272016-09-05
00815802010139BodyMedZZHP1414ZZHP14142016-09-05
00815802010146BodyMedZZHP147ZZHP1472016-09-05
00815802010153BodyMedZZHP832UZZHP832U2016-09-05
00815802018715BodyMedZZHP1427BLKZZHP1427BLK2016-08-01
00815991022623BodyMedZZHPS1623ZZHPS16232019-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253007435MonojectCardinal Health 200, LLCPNR2026-02-19
10192253007503MonojectCardinal Health 200, LLCPNR2026-02-19
10192253007541MonojectCardinal Health 200, LLCPNR2026-02-19
10192253007725MonojectCardinal Health 200, LLCPNR2026-02-19
10850053289672SurgycoSurgyco LLCPNR2025-12-11
10704411006169AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.PNR2025-06-24
10704411007081AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.PNR2025-06-24
10704411007104AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit TipAMSINO INTERNATIONAL, INC.PNR2025-06-24
10827989004273Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-22
08015262020118NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262020132NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262035419NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262035488NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262039301NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
10192253010923KangarooCardinal Health 200, LLCPNR2025-02-04
10827989000091Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10827989000107Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10827989000114Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10827989000121Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10827989000138Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10827989000145Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10192253011050KangarooCardinal Health 200, LLCPNR2024-12-02
00020451101309ENFit Syringe 1mlMedela LLCPNR2024-05-06
10192253011036KangarooCardinal Health 200, LLCPNR2024-03-25
10192253008272KangarooCardinal Health 200, LLCPNR2024-03-08
10192253008289KangarooCardinal Health 200, LLCPNR2024-03-08
16945155741457NANingbo Tianyi Medical Appliance Co., Ltd.PNR2024-02-20
16945155741464NANingbo Tianyi Medical Appliance Co., Ltd.PNR2024-02-20
16945155741471NANingbo Tianyi Medical Appliance Co., Ltd.PNR2024-02-20
16945155741488NANingbo Tianyi Medical Appliance Co., Ltd.PNR2024-02-20