FDA.reportPublic FDA data

PMI

Primary DI
10812608020017
Brand
PMI
Company
PROGRESSIVE MEDICAL, INC.
Model
PMIS2023
Catalog number
PMIS2023
Device description
PMI Straight Huber Needle w/Female Luer Connector 20G x 2 ¾"
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K884211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K884211000STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLESMarquette Medical, Inc.1988-10-17FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812608020017PackageGS112In Commercial Distribution
00812608020010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081260802001710812608020017
00812608020010008126080200108126080200100812608020010

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous injection/infusion port needleA sterile, sharp bevel-edged, hollow tubular metal instrument attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
314-961-5786CS@PROGRESSIVEMEDINC.COM

Regulatory Flags#

DUNS number
192135242
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812608022328PMIPMICC512S2024-11-12
00812608022342PMIPMICCXLKT2024-11-12
00812608022304PMIPMICC5122024-11-12
00812608022335PMIPMICC512S2024-11-12
00812608022359PMIPMICCXLKT2024-11-12
00812608021444PMIK411CK411C2016-09-19
00812608020980PMIPMIORCAP20PMIORCAP202016-10-05
00812608020997PMIPMIXLPINPMIXLPIN2016-09-23
00812608021000PMIPMIXL11PMIXL112016-09-23
00812608021017PMIPMIORCBPMIORCB2016-09-23
00812608021024PMIPMILAP13PMILAP132016-09-23
00812608021031PMIPMIPIN152016-09-23
00812608021062PMIPMIORCA2016-09-23
00812608021529PMIPMIORCAP20PMIORCAP202017-08-01
00812608021543PMIPMIXLPINPMIXLPIN2017-08-01
00812608021734PMIPMICATH20PMICATH202018-01-22
00812608020232PMIPMISG10PMISG102016-09-23
00812608020256PMIPMISG12B2PMISG12B22016-09-23
00812608020270PMIPMISG12B4PMISG12B42016-09-23
00812608020119PMIPMI-500PMI-5002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810011730809huahongTianjin Huahong Technology Co., Ltd.FMI2026-07-10
00810011730816QikDiagTianjin Huahong Technology Co., Ltd.FMI2026-07-10
16972857297784Easydrip Glider5 Classic Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09
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20192253036982MonojectCardinal Health 200, LLCFMI2026-07-09
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20192253037026MonojectCardinal Health 200, LLCFMI2026-07-09
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20192253037040MonojectCardinal Health 200, LLCFMI2026-07-09
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20192253037088MonojectCardinal Health 200, LLCFMI2026-07-09
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20192253038313MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038337MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038368MonojectCardinal Health 200, LLCFMI2026-07-09
00857273002602droplet® pen needlesHTL STREFA S AFMI2026-07-05