FDA.reportPublic FDA data

Halsted Health

Primary DI
00860006105006
Brand
Halsted Health
Company
Flex Source International, Inc.
Model
Part Number: 2523
Device description
Syringes with needle
Published
2021-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060211000WUZHOU SYRINGE, WITH/WITHOUT NEEDLEWenzhou Wuzhou Group Co. , Ltd.2006-02-10FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006105020PackageGS125In Commercial Distribution
00860006105006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006105020008600061050208600061050200860006105020
00860006105006008600061050068600061050060860006105006

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer setA collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
858-539-6246info@halstedhealth.com

Regulatory Flags#

DUNS number
097915269
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860006105044Halsted HealthPart Number: 25232021-02-10
00860010400203Halsted HealthUrinary Bag2023-06-01
00860010400227Halsted HealthUrinary Bag2023-06-01
00860006105037Halsted HealthSize 29MM - # 7729-302022-01-14
00860006105075Halsted HealthSize 32MM - # 7732-302022-01-14
00860006105051Halsted HealthSize 29MM - # 7729-302022-01-14
00860006105099Halsted HealthSize 32MM - # 7732-302022-01-14
00860006105068Halsted HealthPart Number: 25232021-02-10
00860006105020Halsted HealthPart Number: 25232021-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
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05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
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05391530753524Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
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05391530753548Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01