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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Medline Industries, Inc. - 10889942214754

PROCUREMENT
MEDLINE INDUSTRIES, INC.
PHS48732A
In Commercial Distribution

  • 10889942214754 ()
PHS48732A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942214747

NICU KIT
MEDLINE INDUSTRIES, INC.
DYKL1216
In Commercial Distribution

  • 10889942214747 ()
DYKL1216

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942214730

NICU PICC ML INSERTION TRAY
MEDLINE INDUSTRIES, INC.
DYNDC2095A
In Commercial Distribution

  • 10889942214730 ()
DYNDC2095A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942214723

PODIATRY PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ23460C
In Commercial Distribution

  • 10889942214723 ()
  • 40889942214724 ()
DYNJ23460C

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942214709

CHEST KIT
MEDLINE INDUSTRIES, INC.
DYNDA1542
In Commercial Distribution

  • 10889942214709 ()
DYNDA1542

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942214693

CHEST TUBE PACK-LF
MEDLINE INDUSTRIES, INC.
PHS810350B
In Commercial Distribution

  • 10889942214693 ()
PHS810350B

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942214686

MINOR SURGERY PACK-LF
MEDLINE INDUSTRIES, INC.
PHS810371B
In Commercial Distribution

  • 10889942214686 ()
PHS810371B

  • General surgical procedure kit, medicated

Medline Industries, Inc. - 10889942214679

SKIN PREP KIT
MEDLINE INDUSTRIES, INC.
DYNDP1129
In Commercial Distribution

  • 10889942214679 ()
  • 40889942214670 ()
DYNDP1129

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942214631

KNEE ARTHRO LAW CDS-LF
MEDLINE INDUSTRIES, INC.
CDS984179F
In Commercial Distribution

  • 10889942214631 ()
CDS984179F

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942214617

ENDO KIT
MEDLINE INDUSTRIES, INC.
DYKE1227B
In Commercial Distribution

  • 10889942214617 ()
DYKE1227B

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942214594

ANESTHESIA CIRCUIT ADULT-LF
MEDLINE INDUSTRIES, INC.
DYNJAAF6609
In Commercial Distribution

  • 10889942214594 ()
  • 40889942214595 ()
DYNJAAF6609

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942214556

ANES TURNOVER KIT
MEDLINE INDUSTRIES, INC.
DYNJAAF6529B
In Commercial Distribution

  • 10889942214556 ()
  • 40889942214557 ()
DYNJAAF6529B

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942214549

NERVE BLOCK TRAY W/O
MEDLINE INDUSTRIES, INC.
DYNJRA0765
In Commercial Distribution

  • 10889942214549 ()
DYNJRA0765

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942214525

BREAST CDS
MEDLINE INDUSTRIES, INC.
CDS983148A
In Commercial Distribution

  • 10889942214525 ()
  • 40889942214526 ()
CDS983148A

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942214518

ROBOTIC LAP CHOLE
MEDLINE INDUSTRIES, INC.
DYNJ901282D
In Commercial Distribution

  • 40889942214519 ()
  • 10889942214518 ()
DYNJ901282D

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942214501

ROBOTIC PACK
MEDLINE INDUSTRIES, INC.
DYNJ51819
In Commercial Distribution

  • 10889942214501 ()
DYNJ51819

  • General surgical procedure kit, non-medicated, reusable

Verifine - 00850011833605

Blood Lancet is a sterile, handheld, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider or patient self to manually puncture the skin to obtain a small blood specimen.
Promisemed Medical Devices Inc.
BL-28G
In Commercial Distribution

  • 80850011833601 ()
  • 00850011833605 ()
  • 10850011833602 ()


  • Blood lancet, single-use

Verifine - 00850011833568

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7053008-100
In Commercial Distribution

  • 10850011833565 ()
  • 00850011833568 ()
  • 80850011833564 ()


  • Insulin syringe/needle, basic

Verifine - 00850011833551

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7033108-100
In Commercial Distribution

  • 10850011833558 ()
  • 00850011833551 ()
  • 80850011833557 ()


  • Insulin syringe/needle, basic

Verifine - 00850011833537

Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield.
Promisemed Medical Devices Inc.
SL-3018T
In Commercial Distribution

  • 10850011833534 ()
  • 00850011833537 ()
  • 80850011833533 ()


  • Blood lancet, single-use

Verifine - 00850011833506

Blood Lancet is a sterile, handheld, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider or patient self to manually puncture the skin to obtain a small blood specimen.
Promisemed Medical Devices Inc.
BL-30G
In Commercial Distribution

  • 10850011833503 ()
  • 00850011833506 ()
  • 80850011833502 ()


  • Blood lancet, single-use

Verifine - 00850011833490

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-31-04
In Commercial Distribution

  • 10850011833497 ()
  • 00850011833490 ()
  • 80850011833496 ()


  • Autoinjector needle

Verifine - 00850011833483

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-29-12
In Commercial Distribution

  • 10850011833480 ()
  • 00850011833483 ()
  • 80850011833489 ()


  • Autoinjector needle

Verifine - 00850011833445

Blood Lancet is a sterile, handheld, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider or patient self to manually puncture the skin to obtain a small blood specimen.
Promisemed Medical Devices Inc.
BL-33G
In Commercial Distribution

  • 10850011833442 ()
  • 00850011833445 ()
  • 80850011833441 ()


  • Blood lancet, single-use

Verifine - 00850011833438

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-31-08
In Commercial Distribution

  • 10850011833435 ()
  • 00850011833438 ()
  • 80850011833434 ()


  • Autoinjector needle

Verifine - 00850011833421

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-31-05
In Commercial Distribution

  • 10850011833428 ()
  • 00850011833421 ()
  • 80850011833427 ()


  • Autoinjector needle

Verifine - 00850011833278

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-33-04
In Commercial Distribution

  • 10850011833275 ()
  • 00850011833278 ()
  • 80850011833274 ()


  • Autoinjector needle

Verifine - 00850011833261

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-32-06
In Commercial Distribution

  • 10850011833268 ()
  • 00850011833261 ()
  • 80850011833267 ()


  • Autoinjector needle

Verifine - 00850011833254

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-32-05
In Commercial Distribution

  • 10850011833251 ()
  • 00850011833254 ()
  • 80850011833250 ()


  • Autoinjector needle

Verifine - 00850011833247

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-31-06
In Commercial Distribution

  • 10850011833244 ()
  • 00850011833247 ()
  • 80850011833243 ()


  • Autoinjector needle
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