FDA.reportPublic FDA data

Richard Wolf

Primary DI
00817984011195
Brand
Richard Wolf
Company
MECTRA LABS, INC.
Model
0600-2160-000
Catalog number
0600-2160-000
Device description
Hand Pump
Published
2019-01-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAOINSTRUMENT, SURGICAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817984011192PackageGS15Not in Commercial Distribution
20817984011199PackageGS14Not in Commercial Distribution
00817984011195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081798401119210817984011192
2081798401119920817984011199
00817984011195008179840111958179840111950817984011195

GMDN Terms#

Term, Definition table
TermDefinition
General positive-pressure manual hand inflatorA hand-operated manual device designed to draw in ambient air and expel the air from a connected nozzle to inflate a device (e.g., mattress, patient head support rings); it is not intended to be used with invasive devices. It is typically designed as a bicycle pump, a stirrup pump, or a large syringe-like pump, and is designed for use in the home and healthcare facilities. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Fahrenheit115 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-3968mectrasales@mectralabs.com

Regulatory Flags#

DUNS number
606939072
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817984010211Electro Lube0600-EL101-0000600-EL101-0002019-01-24
00817984010228Electro Lube0600-EL102-0000600-EL102-0002019-01-28
00817984010402Electro Lavage0600-3100-0000600-3100-0002019-01-25
00817984010419Electro Lavage0600-3101-0000600-3101-0002019-01-25
00817984010426Electro Lavage0600-3102-0000600-3102-0002019-01-25
00817984010433Electro Lavage0600-3103-0000600-3103-0002019-01-25
00817984010440Electro Lavage0600-3110-0000600-3110-0002019-01-25
00817984010457Electro Lavage0600-3111-0000600-3111-0002019-01-25
00817984010464Electro Lavage0600-3112-0000600-3112-0002019-01-24
00817984010471Electro Lavage0600-3113-0000600-3113-0002019-01-25
00817984010488Electro Lavage0600-3120-0000600-3120-0002019-01-25
00817984010495Electro Lavage0600-3121-0000600-3121-0002019-01-25
00817984010501Electro Lavage0600-3122-0000600-3122-0002019-01-29
00817984010518Electro Lavage0600-3123-0000600-3123-0002019-01-25
00817984010525Electro Lavage0600-3130-0000600-3130-0002019-01-25
00817984010532Electro Lavage0600-3131-0000600-3131-0002019-01-29
00817984010549Electro Lavage0600-3132-0000600-3132-0002019-01-25
00817984010556Electro Lavage0600-3133-0000600-3133-0002019-01-25
00817984010563Electro Lavage0600-3140-0000600-3140-0002019-01-24
00817984010570Electro Lavage0600-3141-0000600-3141-0002019-01-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800508Adler Instrument CompanyAdler, Inc.HAO2026-07-30
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00190776404109MillenniumAvalign Technologies, Inc.HAO2026-07-24
00190776404000MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404017MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404024MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404031MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404048MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404055MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404062MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404079MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776400262MillenniumAvalign Technologies, Inc.HAO2026-07-21
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04058749078794NAFehling Instruments GmbH & Co. KGHAO2026-07-17
00190776400231MillenniumAvalign Technologies, Inc.HAO2026-07-16
00190776395445MillenniumAvalign Technologies, Inc.HAO2026-07-14
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00190776395391MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395407MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395414MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395421MillenniumAvalign Technologies, Inc.HAO2026-07-13
04946329056440CEA Scissors 170 mm, 35 deg. Downward CvdMIZUHO CORPORATIONHAO2026-05-29
04946329056457CEA Scissors 180 mm, Sideward Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329056464CEA Micro Scissors 170 mm, 35 deg. Downward Cvd.MIZUHO CORPORATIONHAO2026-05-29