FDA.reportPublic FDA data

NAMIC

Primary DI
20197344104939
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJINFLATEPO
Catalog number
DYNJINFLATEPO
Device description
INFLATION,DEVICE,20ML,30ATM
Published
2024-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAVSyringe, balloon inflation
PTMSyringe, Balloon Inflation, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAVSyringe, Balloon InflationCardiovascular2
PTMSyringe, Balloon Inflation, ExemptCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170027000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344104939PackageGS15In Commercial Distribution
10197344104932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734410493920197344104939
1019734410493210197344104932

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/overtube balloon inflator, single-useA device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
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
false
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
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856877002780Everis, Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2026-05-20
00884450544648basixCOMPAK™Merit Medical Systems, Inc.PTM2026-04-29
00884450638514basixCOMPAK™Merit Medical Systems, Inc.PTM2026-04-29
10197344203475NAMICMEDLINE INDUSTRIES, INC.PTM2026-03-16
00884450440612basixTOUCH™Merit Medical Systems, Inc.PTM2026-02-20
10889942546350NamicMEDLINE INDUSTRIES, INC.PTM2025-12-18
00884450098684basixTOUCH™Merit Medical Systems, Inc.PTM2025-11-04
00884450220092basixTOUCH™Merit Medical Systems, Inc.PTM2025-11-04
00884450098288basixTOUCH™Merit Medical Systems, Inc.PTM2025-10-07
00724995244538LumiflexUS EndoscopyPTM2025-08-19
00884450021347DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-21
00884450021262DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-19
00884450021255DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-05
00884450860373BIG60™Merit Medical Systems, Inc.PTM2025-05-31
00856877002759QL Disposable Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
00856877002766Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
00856877002773Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
20859500005169StopLockFEMASYS INC.PTM2025-05-02
00884450860113basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-23
00884450860106basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-21
00884450621370basixTOUCH™Merit Medical Systems, Inc.PTM2025-01-15
00884450621394basixTOUCH™Merit Medical Systems, Inc.PTM2025-01-15
10884450822514basixSKY™Merit Medical Systems, Inc.PTM2024-12-28
00884450830697Monarch®Merit Medical Systems, Inc.MAV2024-12-20
00884450851722Monarch®Merit Medical Systems, Inc.MAV2024-10-03
00884450851753Monarch®Merit Medical Systems, Inc.MAV2024-10-03
00884450851760Monarch®Merit Medical Systems, Inc.MAV2024-10-03
10197344104932NAMICMEDLINE INDUSTRIES, INC.PTM2024-09-09
00856877002704Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2024-08-06
10884450822521basixSKY™Merit Medical Systems, Inc.PTM2024-06-18