FDA.reportPublic FDA data

Drop-It™ Quick Release Needle Holders

Primary DI
36641670019241
Brand
Drop-It™ Quick Release Needle Holders
Company
Cardiomed Supplies Inc
Model
1.1
Catalog number
4550
Published
2021-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K963748000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963748000BIO-PLEXUS DROP-IT NEEDLE HOLDERBio-Plexus, Inc.1997-06-06FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36641670019241PrimaryGS10
16641670019230Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3664167001924136641670019241
1664167001923016641670019230

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection tube holder, single-useA hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.

Regulatory Flags#

DUNS number
240623124
Device count
50
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
36641670001314Adult Heart Cooling Jacket2.417-2602021-04-21
36641670001338Adult Heart Cooling Jacket Recirculation Set1.417-260TG2021-04-21
36641670001352Pediatric Heart Cooling Jacket2.017-2622021-04-21
36641670011528rescuCLAMP™ Catheter Repair Clamp1.5CM-6042021-04-21
16641670001303Adult Heart Cooling Jacket2.417-2602021-04-21
16641670001327Adult Heart Cooling Jacket Recirculation Set1.417-260TG2021-04-21
16641670001341Pediatric Heart Cooling Jacket2.017-2622021-04-21
16641670011517rescuCLAMP™ Catheter Repair Clamp1.5CM-6042021-04-21
16641670019230Drop-It™ Quick Release Needle Holders1.145502021-04-21
366416700041793/8'' x 1/4'' x 3/8'' Y Connector2.9C-6602020-12-02
366416700041931/2'' x 3/8'' x 3/8'' Y Connector2.8C-6612020-12-02
366416700042163/8'' x 1/4'' x 1/4'' Y Connector2.0C-6622020-12-02
366416700042301/2'' x 3/8'' x 1/2'' Y Connector2.4C-6632020-12-02
366416700042541/4'' Y Connector w/L.L.2.6C-6642020-12-02
366416700042783/8'' Y Connector w/L.L.2.6C-6652020-12-02
366416700042921/2'' Y Connector w/L.L.1.4C-6662020-12-02
366416700043153/16'' Y Connector w/L.L.1.5C-6672020-12-02
366416700043393/8'' x 1/4'' x 3/8'' Y Connector w/L.L.1.3C-6682020-12-02
366416700043531/2'' x 3/8'' x 3/8'' Y Connector w/L.L.1.6C-6692020-12-02
366416700043773/8'' x 1/2'' x 1/2'' Y Connector w/L.L.2.3C-6702020-12-02

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