FDA.reportPublic FDA data

QUICK-DRAW PLAIN ADAPTER

Primary DI
10857182006088
Brand
QUICK-DRAW PLAIN ADAPTER
Company
Innovative Medical Technologies, Inc.
Model
15-900
Device description
QUICK-DRAW PLAIN ADAPTER FOR USE WITH INNOVAC
Published
2016-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GIOTube, Collection, Capillary Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIOTube, Collection, Capillary BloodHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972969000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972969000QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEMInnovative Medical Technologies, Inc.1997-09-22GIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20857182006085PackageGS15In Commercial Distribution
10857182006088PrimaryGS10
00857182006081Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085718200608520857182006085
1085718200608810857182006088
00857182006081008571820060818571820060810857182006081

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood transfer tube IVD, EDTAA non-sterile glass or plastic capillary blood transfer tube coated internally with the anticoagulant ethylenediaminetetraacetic acid (EDTA), and intended to be attached to a non-evacuated blood collection tube to assist with the transfer of blood drops from the blood collection site into the collection tube using a capillary action. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
866-560-1820support@innovativemedtech.com

Regulatory Flags#

DUNS number
792740578
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10857182006477ULTRAFLO-R3633632025-02-13
10857182006484ULTRAFLO-R3643642025-02-13
10857182006491ULTRAFLO-R3653652025-02-13
10857182006507ULTRAFLO-R6876872025-02-13
10857182006576ULTRAFLO-R3233232025-02-13
10857182006583ULTRAFLO-R3243242025-02-13
10857182006590ULTRAFLO-R3263262025-02-13
40857182006508ULTRAFLO-R6886882025-02-13
70857182006509ULTRAFLO-R6896892025-02-13
00857182006265ULTRAFLO-R3383382025-02-13
00857182006623ULTRAFLO-R3363362025-02-13
00857182006661ULTRAFLO-R3353352025-02-13
10857182006330UltraFlo-S2852026-03-12
20857182006337ULTRAFLO-S2852025-02-14
00857182006784UltraFlo-C6810052025-12-30
00857182006807UltraFlo-C6820052025-12-30
10857182006002INNOSET5961212016-06-06
10857182006026INNOSET5961252016-06-06
10857182006170ULTRAFLO-S2832025-02-14
10857182006224ULTRAFLO-V6086082025-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850059420515SAFECAPDRUMMOND SCIENTIFIC COMPANYGIO2026-05-18
00850059420492MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2026-04-17
00850059420508MICROSAFEDRUMMOND SCIENTIFIC COMPANYGIO2026-04-17
00857182006784UltraFlo-CInnovative Medical Technologies, Inc.GIO2025-12-30
00857182006807UltraFlo-CInnovative Medical Technologies, Inc.GIO2025-12-30
00848530108113DIATUBE002SUNSET HEALTHCARE SOLUTIONS, INC.GIO2025-12-23
10848530108110DIATUBE002SUNSET HEALTHCARE SOLUTIONS, INC.GIO2025-12-23
00381934774015PTS Diagnostics Capillary TubesPOLYMER TECHNOLOGY SYSTEMS, INC.GIO2025-06-16
10381934774012PTS Diagnostics Capillary TubesPOLYMER TECHNOLOGY SYSTEMS, INC.GIO2025-06-16
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