FDA.reportPublic FDA data

ELMED

Primary DI
00850011214350
Brand
ELMED
Company
PROGRESSIVE MEDICAL INSTRUMENTATION INC
Model
PMI4207021
Catalog number
PMI4207021
Device description
"SUCTION, OPEN TIP W/FINGER CONTROL 11"""
Published
2019-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011214350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011214350008500112143508500112143500850011214350

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration handpiece, reusableA hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5022671100ORDERS@PMIREPAIRS.COM

Regulatory Flags#

DUNS number
131054074
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011214442ELMEDPMI23-40045STRPMI23-40045STR2019-12-06
00850011214404AVALIGNPMI-HD-SPMI-HD-S2019-11-20
00850011214411AVALIGNPMI-B-2VPMI-B-2V2019-11-20
00850011214428AVALIGNPMI-B-3VPMI-B-3V2019-11-20
00850011214435AVALIGNPMI-ABB-11VPMI-ABB-11V2019-11-20
00850011214299AVALIGNPMI-ABB-33VPMI-ABB-33V2019-09-20
00850011214282AVALIGNPMI-ABB-22VPMI-ABB-22V2019-09-18
00850011214077AVALIGNPMI-RD-DPMI-RD-D2019-09-06
00850011214084AVALIGNPMI-HD-DPMI-HD-D2019-09-06
00850011214091AVALIGNPMI-DC-1-BPMI-DC-1-B2019-09-06
00850011214107AVALIGNPMI-B3-VBPMI-B3-VB2019-09-06
00850011214497ELMEDPMI37-500707PMI37-5007072020-02-18
00850011214473ELMEDPMI59-8010BMPMI59-8010BM2020-01-03
00850011214459ELMEDPMI52-25560B1PMI52-25560B12019-12-23
00850011214466ELMEDPMI52-25566B1PMI52-25566B12019-12-23
00850011214381ELMEDPMI52-25571A1PMI52-25571A12019-11-15
00850011214398ELMEDPMI52-205100PMI52-2051002019-11-15
00850011214374ELMEDPMI52-00548PMI52-005482019-11-01
00850011214329ELMEDPMI422010PMI4220102019-10-01
00850011214336ELMEDPMI425301PMI4253012019-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874957506Create BiotechCREATE BIOTECH CO., LTD.CCW2026-07-21
10884521859999McGRATH MAC+Covidien LPCCW2026-07-03
04053755200122visionPRO Set MacHeine Optotechnik GmbH & Co. KGCCW2026-06-24
04053755213092MEDUVISION Set MacHeine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213108MEDUVISION Mac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213115MEDUVISION Mac 2 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213122MEDUVISION Mac 4 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213139MEDUVISION HyMac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
00842209139149NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139156NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139163NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139170NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139187NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139194NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139200NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00810055257607Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257614Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257621Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257638Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257645Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257652Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257669Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257676Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257683Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257690Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257706Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257713Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257720Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257737Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055251339Surgical DesignSurgical Design, Inc.CCW2026-06-09