FDA.reportPublic FDA data

ARROW

Primary DI
30801902120138
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN036831
Catalog number
AK-01000-T
Device description
Arrow-Clarke(TM) Pleura-Seal(R) Thoracentesis Kit
Published
2017-08-22
Public version status
Update
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
JOLCATHETER AND TIP, SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K870572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K870572000ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KITArrow Intl., Inc.1987-05-26JOL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30801902120138PackageGS110Not in Commercial Distribution
20801902120131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3080190212013830801902120138
2080190212013120801902120131

GMDN Terms#

Term, Definition table
TermDefinition
Pneumothorax catheter insertion setA collection of devices used to puncture the chest wall to enable insertion of a dedicated catheter for the aspiration of a simple pneumothorax or decompression of a tension pneumothorax. It typically consists of a scalpel to make a stab incision and a needle to assist the entry of the catheter with obturator assembly (to protect the internal organs upon entry). Once the catheter is in place, the needle is retracted to allow the flow of air/fluid from within the chest cavity. The set may contain suture for the attachment of the catheter to the skin. It is typically used for accident and emergency (A&E) situations (immediate care or chest crush injury). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10080196035434MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-16
10080196995554MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-13
10192253039665CARDINAL HEALTHCardinal Health 200, LLCJOL2025-12-16
07613327680720Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
10197344153671MEDLINEMEDLINE INDUSTRIES, INC.JOL2025-05-21
10192253041866ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253041873ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253041880ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253038941ArgyleCardinal Health 200, LLCJOL2025-02-28
10192253038958ArgyleCardinal Health 200, LLCJOL2025-02-28
10192253039672ArgyleCardinal Health 200, LLCJOL2024-12-04
10192253003628ArgyleCardinal Health 200, LLCJOL2024-10-09
10192253002928ArgyleCardinal Health 200, LLCJOL2024-09-27
10192253002935ArgyleCardinal Health 200, LLCJOL2024-09-27
10192253002942ArgyleCardinal Health 200, LLCJOL2024-09-27
10192253057294ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057300ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057317ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057324ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057348ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057355ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057362ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057379ArgyleCardinal Health 200, LLCJOL2024-08-02